Minhtc-rio de Salud

Gobierno de Chile

CERTIFICADO
REVISIÓN DE ANTECEDENTES QUE ACOMPAÑAN AL DISPOSITIVO MÉDICO
Nº DOM/ 2146 / 19

El Departamento Dispositivos Médicos del Instituto de Salud Pública de Chile, ha recibido los antecedentes
presentados por la empresa Global Partners SpA., para la conformidad de los siguientes dispositivos médicos:

Test Rápidos para la detección de drogas

lnmunoensayos para la detección cualitativa de drogas de abuso
Clase B (11)

Fabricante Legal Hangzhou Ali Test Biotech Co. Ltd.

Dirección #550, Yinhai Street Hangzhou, Zhejiang, 310018, China
Planta de Fabricación Hangzhou Ali Test Biotech Co. Ltd.
Dirección #550, Yinhai Street Hangzhou, Zhejiang, 310018, China
Distribuidor en Chile: Global Partners SpA.
Dirección Lota 2257, Oficina 901, Providencia, Santiago, Chile.

USO PREVISTO POR EL FABRICANTE:

Indicado para la detección rápida y cualitativa de drogas de abuso y a utilizar con distintos tipos de muestras
(ver Anexo).

DESCRIPCIÓN DEL DISPOSITIVO MÉDICO:

Familia de test rápidos de lectura visual basados en técnicas de inmunocromatografía. No requiere el uso de
instrumental especial. Detecta selectivamente la presencia de drogas existentes en la muestra. Se indican los
puntos de corte de cada droga, a partir de los cuales se considera un resultado positivo demostrado por la
aparición de una línea coloreada en la zona de prueba del dispositivo (ver Anexo).

CÓDIGO UMDNS: 19-196: Reactivos/Kits para ensayos de DIV, lnmunoensayo, Rápido, Droga de hábito.

A través de este certificado se otorga conformidad a los antecedentes tenidos a la vista y se deja constancia
que el producto cuenta con la siguiente certificación:

1. Certificado para Gobierno Extranjero, Nº 15001- 9- 2017 emitido por la Food and Drug Administration de
Estados Unidos (FDA), certificando que los productos fabricados por Hangzhou Ali Test Biotech Co. Ltd. de
China (ver listado en Anexo), pueden ser comercializados en Estados Unidos y legalmente exportados. La
planta de fabricación de estos productos está sujeta a inspecciones periódicas. Válido hasta el 19 de
septiembre de 2019.

2. Certificado del Sistema de Gestión de Calidad, Nº Q5 0951 23 0007 Rev. 01 otorgado por TOV sOo Product
Service GmbH, certificando que Hangzhou Ali Test Biotech Co. Ltd. de China, tiene implementado un Sistema
de Gestión de Calidad que cumple con los requisitos de la Norma EN ISO 13485:2016 que aplica a las
actividades de diseño y desarrollo, producción y distribución de kits para diagnóstico in vitro de drogas de
Avabt;1!!01~Cél'lf~Nrfeclades infecciosas entre otros. Válido hasta el 24 de septiembre de 2020.
(asilla 4~. CDnL-0 21 - Código FostJI 77800,0
Mesa Central 156) 22575 51 01
I11formaC1ones 1561225755201 Página 1 de 13
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 M1.nt\tetio d1 Salud

Goblemo de Chile

CERTIFICADO
REVISIÓN DE ANTECEDENTES QUE ACOMPAÑAN AL DISPOSITIVO MÉDICO
Nº DOM/ 2146 / 19

3. Carta de Autorización, emitida por el fabricante Hangzhou All Test Biotech Co. ltd. de China; autorizando a
Global Partners SpA: domiciliado en Lota Nº 2257, Oficina 901, Providencia, Santiago, Chile, como su
distribuidor autorizado de la línea de productos All Test para Chile. Emitido el 14 de enero de 2019.

Estos dispositivos médicos actualmente no se encuentran sometidos a exigencia de registro sanitario en

Chile y la seguridad, calidad y efectividad de éstos, es de exclusiva responsabilidad del fabricante legal,
importador y distribuidor.

El presente documento se otorga a solicitud del interesado y está sujeto a la vigencia de los documentos que
lo respaldan.

k~ -
MARÍA c?c1l1~P{;Gu~
~Ez
JEFA (S)
RTAMENTO DISPOSITIVOS M~DICOS
TITUTO DE SALUD PÚBLICA DE CHILE

Sistema de Tecnovigilancia !Artículo 28 Reglamento D.S. 825/1998)

El sistema de Tecnovigilancia corresponde a un conjunto de actividades encaminadas a la prevención, detección, investigación y
difusión oportuna de información sobre eventos adversos con dispositivos médicos durante su uso, que puedan generar algún daño al
usuario, al operador o al medio ambiente que lo rodea. Este sistema se sustenta en la notificación de eventos adversos por parte de
profesionales de la salud.
Profesionales de la Salud: Favor notificar cualquier evento adverso asociado a los dispositivos médicos mediante el
Formulario DDM/006 o el Formulario DDM/010 si se trata de un reactivo de diagnóstico in vitro.
Fabricante/importador: Favor notificar las investigaciones de eventos adversos, mediante el formulario DDM/008.
Todos los formularios están disponibles en la página web http:llwww.ispch.cl/Dispositivos Médicos/Tecnovigilancia.
Estos formularios se deben enviar completos con letra legible al correo tecnovigilancia@ ispch.cl

Santiago, 12 de julio de 2019.

~~J~
Nº Ref.: 2968/19
Arch. 2146- 19v Ooc

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 a ns I u o e
Salud Pública -
Mlnhtc-r1o dl' Salud

Gobi~mo de Chile

ANEXO CERTIFICADO
REVISIÓN DE ANTECEDENTES QUE ACOMPAÑAN AL DISPOSITIVO MÉDICO
Nº DDM / 2146 / 19

Listado de Productos

Cat. No. Descripción del Producto Muestra Formato Punto de corte

DABP-102 AB -PINACA (ABP) Rapid Test Cassette Urine Cassette

DABP-114 AB-PINACA (ABP) Rapid Test Panel Urine Panel

10 ng/ml *
DABP- 101 AB-PINACA (ABP) Rapid Test Dipstick Urine Dipstick

DAC-102 Acetaminophen (ACE) Rapid Test Cassette Urine Cassette

DAC-114 Acetaminophen CACE) Rapid Test Panel Urine Panel

5000 ng/ml •
DAC- 101 Acetaminophen (ACE) Rapid Test Dipstick Urine Dipstick
I/ -Ammoclonazepam U -ALU Kap1d I est
DACL-102 Cassette Urine Cassette

DACL-114 7-Aminoclonazepam (7-ACU Rapid Test Panel Urine Panel

300 ng/mL•
DACL- 101 7-Aminoclonazepam (7-ACU Rapid Test Dipstick Urine Dipstick

DAL- 102 Alcohol {ALC) Rapid Test Cassette Urine Cassette

DAL- 114 Alcohol (ALC) Rapid Test Panel Urine Panel

0.02%
DAL- 101 Alcohol (ALC) Rapid Test Dipstick Urine Dipstick

DAM- 102 Amphetamine (AMP) Rapid Test Cassette Urine Cassette

300 ng/ml ,
DAM- 114 Amphetamine (AMP) Rapid Test Panel Urine Panel
500 ng/mL.
DAM- 101 Amphetamine <AMP) Rapid Test Dipstick Urine Dipstick
1000 ng/ml•
cr-l'yrro11d1nova1eropnenone lcr-t'Vt' J Kap1d
DAP- 102 Test Cassette Urine Cassette
o-1-1yrro1101novaIerophenone lo-n.- 1 KapIa I est 1000 ng/ml •,
DAP-114 Panel Urine Panel
o-l'yrro11aInovaIeropnenone (o-t'Vt' J Hap1a I est 500ng/ml,
DAP-101 Dipstick Urine Dipstick
300ng/ml

DBA- 102 Barbiturate (BAR) Rapid Test Cassette Urine Cassette

OBA-114 Barbiturate (BAR) Rapid Test Panel Urine Panel 200 ng/ml.
DBA- 101 Barbiturate (BAR) Rapid Test Dipstick Urine Dipstick 300ng/ml •

DBU - 102 Buprenorphine (BUP) Rapid Test Cassette Urine Cassette

DBU- 114 Buprenorphine (BUP) Rapid Test Panel Urine Panel

10 ng/ml*
DBU- 101 Buprenorphine (BUP) Rapid Test Dipstick Urine Dipstick

DBZ-102 Benzodiazepines (BZO) Rapid Test Cassette Urine Cassette

100 ng/ml, 200
DBZ- 114 Benzodiazepines (BZO) Rapid Test Panel Urine Panel
ng/ml,
DBZ- 101 Benzodiazepines (BZO) Rapid Test Dipstick Urine Dipstick 300 n11/ml*
DCA- 102 Cathine (CAT) Rapid Test Cassette Urine Cassette

DCA-114 n
Cathine (CA Rapid Test Panel Urine Panel
150 ng/ml *
DCA-101 Cathine (CAT) Rapid Test Dipstick Urine Oipstick

DCAF-102 Caffeine(CAF) Rapid Test Cassette Urine Cassette

DCAF- 114 Caffeine(CAF) Rapid Test Panel Urine Panel

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 nst1tuto e
Salud Püblica
JJin1u,r10 d~ Salud

Gobierno de Chile

ANEXO CERTIFICADO
REVISIÓN DE ANTECEDENTES QUE ACOMPAÑAN AL DISPOSITIVO MÉDICO
Nº DOM / 2146 / 19

OCAF-101 Caffeine(CAF) Rapid Test Oipstick Urine Oipstick 1000 ng/mL •

OCL-102 Clonazepam ((LO) Rapid Test Cassette Urine Cassette

OCL-114 Clonazepam (CLO) Rapid Test Panel Urine Panel

400 ng/ml *
OCL- 101 Clonazepam (CLO) Rapid Test Oipstick Urine Oipstick

OC0-102 COCAINE (COO Rapid Test Cassette Urine Cassette

100 ng/mL,
OC0- 114 COCAINE ((OC) Rapid Test Panel Urine Panel
150 ng/ml,
OC0-101 COCAINE (COO Rapid Test Dipstick Urine Dipstick
300ng/mL·

DCT-102 Cotinine (COT) Rapid Test Cassette Urine Cassette

50 ng/mL,
OCT-114 Cotinine (COT) Rapid Test Panel Urine Panel
lOOng/mL,200
OCT-101 Cotinine (COn Rapid Test Oipstick Urine Oipstick ng/mL•, 500 ng/mL

OCFY-102 Carfentanyl(CFYU Rapid Tests Cassette Urine Cassette

OCFY-114 Carfentanyt<CFYU Rapid Tests Panel Urine Panel

500 ng/mL•
OCFY-101 Carfentanyl(CFYU Rapid Tests Oipstick Urine Dipstick

001- 102 Oiazepam <DIA) Rapid Test Cassette Urine Cassette

001-114 Oiazepam <DIA) Rapid Test Panel Urine Panel

300 ng/mL•
001-101 Oiazepam <DIA) Rapid Test Dipstick Urine Oipstick
lt thDlened1am1ne-d1methylphosph1nic ac1d
OED-102 (ED P) Rapid Test Cassette Urine Cassette
,ttnD1enecllamme-d1memy1pnosph1nic ac1d
DE0-114 (EO P) Rapid Test Panel Urine Panel
ttnti1eneaiamme-a1metnrpnospnm1c ac,a 100 ng/ml •
OED-101 (ED P) Rapid Test Oipstic Urine Oipstick

OET-102 Ethyl Glucuronide (ETG) Rapid Test Cassette Urine Cassette

OET- 114 Ethyl Glucuronide (ETG) Rapid Test Panel Urine Panel 500ng/mL •,
OET-101 Ethyl Glucuronide (ETG) Rapid Test Oipstick Urine Dipstick 1000 ng/mL

OFY- 102 Fentanyl (FYU Rapid Test Cassette Urine Cassette

OFY- 114 Fentanyl (FYU Rapid Test Panel Urine Panel 10 ng/mL ,20 ng/mL •
OFY-101 Fentanyl (FYU Rapid Test Oipstick Urine Oipstick
t Hydroxybutync ac1d 1\Jntll 1<ap1a I est
OGHB-102 asse tte Urine Cassette lOµg/mL

OKE -102 Ketamine (KET)Rapid Test Cassette Urine Cassette

OKE- 114 Ketamine (KETJRapid Test Panel Urine Panel 500 ng/mL,
OKE -101 Ketamine (KET)Rapid Test Oipst ick Urine Oipstick 1000 ng/ml •
10- Monoacety1morpnme lb- MAMI Kap1d 1est
OMA- 102 Cassette Urine Cassette
lb- Monoacetylmorphme (ó- MAM)Rap1a Test
OMA-114 Panel Urine Panel
lb- Monoacetylmorphmelb- MAMJ flap1d I est 10 ng/mL •
OMA-101 Oipstick Urine Oipst ick

OMCA- 102 Methcat hinone(MCAT) Rapid Test Cassette Urine Cassette

OMCA- 114 Methcat hinone(MCAT) Rapid Test Panel Urine Panel

500 ng/ml
OMCA- 101 Methcathinone(MCAT) Rapid Test Oipstick Urine Oipstick

OM0 -102 Ecstasy (MDMAI Rapid Test Cassel te Urine Cassette

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 Salud Püblic1

Gobierno de C1111t

ANEXO CERTIFICADO
REVISIÓN DE ANTECEDENTES QUE ACOMPAÑAN AL DISPOSITIVO MÉDICO
Nº DOM / 2146 / 19

OM0- 114 Ecstasy (MOMA) Rapid Test Panel Urine Panel

500ng/mL•.
OMD- 101 Ecstasy (MOMA) Rapid Test Oipstick Urine Dipstick
1000 ng/ml

DMOA- 102 Tenamfetamine (MOA) Rapid Test Cassette Urine Cassette

OMOA- 114 Tenamfetamine (MOA) Rapid Test Panel Urine Panel

500 ng/ml •
OMDA- 101 Tenamfetamine (MOA) Rapid Test Oipst ick Urine Oipstick
IMethtened1oxypyrovalerone \MUt'VJ Rap1d
DMDP- 102 Test assette Urine Cassette
Meth~tened10xypyrova1erone IMUPVl Kap1d 1000 ng/ml •,
DMDP- 114 Test anel Urine Panel
MetnD1eneaioxypyrova1erone (MUt'VJ Rap1d 500ng/ml,
OMOP- 101 Test ipstick Urine Dipstick
300ng/ml

OMP- 102 Methylphenidate(MPO) Rapid Test Cassette Urine Cassette

DMP- 114 Methylphenidate(MPO) Rapid Test Panel Urine Panel 1000 ng/ml•
OMP- 101 Methylphenidate(MPO) Rapid Test Oipstick Urine Oipstick 300 ng/ml

OME- 102 Methamphetamme (METI RapidTest Cassette Urine Cassette

300 ng/mL.
DME- 114 Methamphetamine (MET) Rapid Test Panel Urine Panel
500 ng/mL.
OME- 101 Methamphetamme (MET) Rapid Test D1pstick Urine Dipstick
1000 ng/ml •

DMEP- 102 Mephedrone HCHMEP) Rapid Test Cassette Urine Cassette

DMEP- 114 Mephedrone HCHMEP) Rapid Test Panel Urine Panel

100 ng/ml
DMEP- 101 Mephedrone HCHMEP) Rapid Test Oipstick Urine Dipstick

OM0 - 102 Morphine (MOP) Rapid Test Cassette Urine Cassette

OM0 - 114 Morphine (MOP) Rapid Test Panel Urine Panel 100 ng/ml,
OM0 - 101 Morphine (MOP) Rapid Test Dipstick Urine Oipstick 300ng/ml •

OMQ- 102 Methaqualone (MQU Rapid Test Cassette Urine Cassette

DMQ- 114 Methaqualone (MQU Rapid Test Panel Urine Panel

300 ng/ml•
DMQ- 101 Methaqualone (MQU Rapid Test Dipstick Urine Oipstick

OMT- 102 Methadone (MTO) Rapid Test Cassette Urine Cassette

OMT- 114 Methadone (MTO) Rapid Test Panel Urine Panel 200 ng/ml,
DMT- 101 Methadone (MTO) Rapid Test Dipstick Urine Oipstick 300ng/ml •

DOP-102 Opiates (OPI) Rapid Test Cassette Urine Cassette

DOP-114 Op1ates (OPI) Rapid Test Panel Urine Panel

2000 ng/ml'
DOP- 101 Opiates (OPI) Rapid Test Dipstick Urine Oipstick

DOX 102 Oxyc odone (OXY) Rapid Test Cassett e Urine Cassette
DDX-11 4 Oxycodone (OXYJ Rapid Test Panel Urine Panel
100 ng/ml •
DOX 101 Oxycodone (OXY) Rapid Test 01pst 1ck Urine D1prnck
DPC-102 Phencycl1dme (PCP) Rap1d Te~t Cassett e Urine Ca11ette
DPC-11 4 Phencychd1ne (PCPJ Ra¡lld Te~t Panel Urlne Pand
25 ng/ml •
DPC-101 Phencychdme (PCP) Rapid fo11 Oipstick UIIIH! 01pmck
DPG-102 Pregabal1n (PGBJRapid Test Cassette Urine Cassette
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 M1nh t~rio dt Salud

Gobierno de Chile

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REVISIÓN DE ANTECEDENTES QUE ACOMPAÑAN AL DISPOSITIVO MÉDICO
Nº DOM / 2146 / 19

OPG-114 Pregabalin (PGB) Rapid Test Panel Urine Panel

50µg/mL•
OPG-101 Pregabalin (PGB) Rapid Test Dipstick Urine Dipstick

OPP- 102 Propoxyphene (PPX) Rapid Test Cassette Urine Cassette

OPP-114 Propoxyphene (PPX) Rapid Test Panel Urine Panel

300 ng/ml•
DPP-101 Propoxyphene (PPX) Rapid Test Dipstick Urine Oipstick

DSM- 102 Synthetic Marijuana (K2) Rapid Test Cassette Urine Cassette

DSM- 114 Synthetic Marijuana (K2) Rapid Test Panel Urine Panel 50ng/mL•,
DSM- 101 Synthetic Marijuana (K2) RapidTest Dipstick Urine Oipstick 30 ng/ml,
1ncyclJC Antidepressan ts \ 1U \/ Rap1d I est
OTC-102 Cassette Urine Cassette

OTC-114 Tricyclic Antidepressants ílCA) Rapid Test Panel Urine Panel 500 ng/ml.1000
1ncycllc Ant1oepressants \ ITA) Rap1d Test
DTC-101 Oipstick Urine Oipstick ng/mL•

DTH- 102 Marijuana (THC) Rapid Test Cassette Urine Cassette 25 ng/mL,20
ng/ml, 50
DTH- 114 Marijuana (THC) Rapid Test Panel Urine Panel
ng/ml*, 150
DTH- 101 Marijuana (THC) Rapid Test Dipstick Urine Dipstick
ng/ml.300
ng/ml

DTM-102 Tramado! (TMU Rapid Test Cassette Urine Cassette

100 ng/ml *,200
DTM -114 Tramado! !TMU Rapid Test Panel Urine Panel
ng/mL. 300 ng/ml
DTM- 101 Tramado! (TMU Rapid Test Oipstick Urine Oipstick

OTR0-102 TropicmideCTROlRapid Test Cassette Urine Cassette

OTR0 -114 TropicmideCTRO)Rapid Test Panel Urine Panel

350 ng/ml*
OTR0-101 Tropicmide(TRO) Rapid Test Dipstick Urine Dipstick
llyserg1c Acid D1ethylamide (LSD) Rapid l est
DLS-102 Cassette Urine Cassette
llyserg1c ACld D1ethylam1de (LSD) Rap1d l est 10 ng/ml,20
DLS-114 Panel Urine Panel
ILysergJC ACld u1ett1ylam1de (l)U) Kapld I est ng/ml*, 50 ng/ml
DLS-101 DipstJCk Urine Dipstick

DZ0-102 Zolpidem(ZOU Rapid Test Cassette Urine Cassette

DZ0-114 Zolpidem(ZOU Rapid Test Panel Urine Panel

50 ng/ml*
DZ0-101 Zolpidem(ZOU Rapid Test Dipstick Urine Dipstick

DALP-102 Alprazolam(ALP) Rapid Test Cassette Urine Cassette

DALP-114 Alprazolam(ALP) Rapid Test Panel Urine Panel

100 ng/ml*
DALP-101 Alprazolam(ALP) Rapid Test Dipstick Urine Dipstick

DZOP-102 Zopiclone(ZOP) Rapid Test Cassette Urine Cassette

DZOP-114 Zopiclone(ZOP) Rapid Test Panel Urine Panel

50 ng/ml *
DZOP-101 Zopiclone(ZOP) Rapid Test Dipstick Urine Dipstick

OAT- 111 Adulteration Dipstick Urine Dipstick /

DOA- 125 Multi-Drug 2 Drugs Rapid Test Cassette Urine Cassette
DOA- 135 Multi- Drug 3 Drugs Rapid Test Cassette Urine Cassette
DOA- 145 Multi-Drug 4 Drugs ílapid Test Cassette Urine Cassette
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 Salud Pública
l\.liruu~rto de S.11ud

Gobiemo de Chile

ANEXO CERTIFICADO
REVISIÓN DE ANTECEDENTES QUE ACOMPAÑAN AL DISPOSITIVO MÉDICO
Nº DOM / 2146 / 19

00A-155 Multi-0rug 5 0rugs Rapid Test Cassette Urine Cassette

00A-165 Multi-0rug 6 0rugs Rapid Test Cassette Urine Cassette
0OA-175 Multi-0rug 7 0rugs Rapid Test Cassette Urine Cassette
00A- 185 Multi-0rug 8 0rugs Rapid Test Cassette Urine Cassette
00A- 195 Multi- 0rug 9 0rugs Rapid Test Cassette Urine Cassette
00A- 1105 Multi- 0rug 10 0rugs Rapid Test Cassette Urine Cassette /

00A- 1115 Multi- 0rug 11 0rugs Rapid Test Cassette Urine Cassette
0OA- 1125 Multi-0rug 12 0rugs Rapid Test Cassette Urine Cassette
00A-124 Multi- 0rug 2 Drugs Rapid Test Panel Urine Panel

00A- 134 Multi- 0rug 3 Drugs Rapid Test Panel Urine Panel
00A- 144 Multi-0rug 4 0rugs Rapid Test Panel Urine Panel

00A-154 Multi-0rug 5 0rugs Rapid Test Panel Urine Panel

00A- 164 Multi-Drug 6 Drugs Rapid Test Panel Urine Panel

0OA- 174 Multi-0rug 7 Drugs Rapid Test Panel Urine Panel

0OA- 184 Multi- 0rug 8 0rugs Rapid Test Panel Urine Panel

0OA- 194 Multi- 0rug 9 Drugs Rapid Test Panel Urine Panel

0OA- 1104 Multi- 0rug 10 0rugs Rapid Test Panel Urine Panel

0OA-1114 Multi- 0rug 11 0rugs Rapid Test Panel Urine Panel

00A- 1124 Multi-0rug 12 0rugs Rapid Test Panel Urine Panel

0OA-1134 Multi-0rug 13 Drugs Rapid Test Panel Urine Panel /

0OA-1144 Multi-0rug 14 0rugs Rapid Test Panel Urine Panel

00A-1154 Multi- 0rug 15 0rugs Rapid Test Panel Urine Panel

0OA-1164 Mult i-Drug 16 0rugs Rapid Test Panel Urine Panel

00A- 127-Al Multi- 0rug 2 0rugs Rapid Test 1- Step Cup Urine Cup

0OA- 137-Al Multi- 0rug 3 0rugs Rapid Test 1- Step Cup Urine Cup

0OA- 147-Al Multi-0rug 4 0rugs Rapid Test 1-Step Cup Urine Cup

0OA- 157-Al Multi-0rug 5 0rugs Rapid Test 1-Step Cup Urine Cup

00A- 167-Al Multi- 0rug 6 0rugs Rapid Test 1- Step Cup Urine Cup

OOA-177-Al Multi- 0rug 7 0rugs Rapid Test 1- Step Cup Urine Cup

00A- 187-Al Multi-0rug 8 0rugs Rapid Test 1- Step Cup Urine Cup

00A- 197-Al Multi-0rug 9 0rugs Rapid Test 1- Step Cup Urine Cup

D0A-1107-Al Multi-Drug 10 0rugs Rapid Test 1-Step Cup Urine Cup

D0A-1117-Al Multi-0rug 11 0rugs Rapid Test 1- Step Cup Urine Cup

00A-1127-Al Multi- 0rug 12 0rugs Rapid Test 1- Step Cup Urine Cup /
D0A-1137-Al Multi-Drug 13 0rugs Rapid Test 1-St ep Cup Urine Cup

D0A-1147-Al Multi-0rug 14 0rugs Rapid Test 1- Sl ep Cup Urine Cup

00A-1157-Al Multi-Drug 15 0rugs Rapid Test 1- Step Cup Urine Cup

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~~
Salud Püblica
M1J'lhlería dt Si\u•

Gobierno de Chile

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Nº DDM / 2146 / 19

DOA- 127-A2 Multi-Drug 2 Drugs Rapid Test 1- Step Cup Urine Cup

DOA-137- A2 Multi-Drug 3 Drugs Rapid Test 1- Step Cup Urine Cup

DOA- 147-A2 Multi-Drug 4 Drugs Rapid Test 1- Step Cup Urine Cup

DOA- 157- A2 Multi-Drug 5 Drugs Rapid Test 1- Step Cup Urine Cup

DOA- 167- A2 Multi- Orug 6 Drugs Rapid Test 1- Step Cup Urine Cup

OOA- 177-A2 Multi- Drug 7 Drugs Rapid Test 1- Step Cup Urine Cup

DOA-187 - A2 Multi-Drug 8 Drugs Rapid Test 1- Step Cup Urine Cup

DOA- 197- A2 Multi- Orug 9 Drugs Rapid Test 1- Step Cup Urine Cup
/
DOA-1107-A2 Multi-Drug 10 Drugs Rapid Test 1- Step Cup Urine Cup

DOA-1117-A2 Multi-Drug 11 Drugs Rapid Test 1- Step Cup Urine Cup

DOA-1127-A2 Multi-Drug 12 Drugs Rapid Test 1- Step Cup Urine Cup

DOA- 127-A3 Multi-Drug 2 Drugs Rapid Test 1- Step Cup Urine Cup

DOA- 137-A3 Multi-Drug 3 Drugs Rapid Test 1-St ep Cup Urine Cup

DOA- 147-A3 Multi-Drug 4 Orugs Rapid Test 1- Step Cup Urine Cup

DOA- 157- A3 Multi-Drug 5 Drugs Rapid Test 1- Step Cup Urine Cup

DOA- 167- A3 Multi-Drug 6 Drugs Rapid Test 1- Step Cup Urine Cup

DOA- 177-A3 Multi-Drug 7 Drugs Rapid Test 1- Step Cup Urine Cup

DOA- 187-A3 Multi-Drug 8 Drugs Rapid Test 1- Step Cup Urine Cup

DOA- 197- A3 Multi-Drug 9 Drugs Rapid Test 1- Step Cup Urine Cup

DOA- 1107-A3 Multi-Drug 10 Drugs Rapid Test 1- Step Cup Urine Cup

DOA- 1117-A3 Multi-Drug 11 Drugs Rapid Test 1- Step Cup Urine Cup

DOA-1127-A3 Multi-Drug 12 Drugs Rapid Test 1- Step Cup Urine Cup /

DOA-1137-A3 Multi-Drug 13 Drugs Rapid Test 1- Step Cup Urine Cup

DOA-1 147-A3 Multi-Drug 14 Drugs Rapid Test 1- Step Cup Urine Cup

DOA-1157- A3 Multi- Orug 15 Drugs Rapid Test 1- Step Cup Urine Cup

DOA- 127-B1 Multi-Drug 2 Drugs Rapid Test 2- Step Cup Urine Cup

DOA- 137- B1 Multi-Drug 3 Drugs Rapid Test 2- Step Cup Urine Cup

DOA- 147- B1 Multi-Drug 4 Drugs Rapid Test 2- Step Cup Urine Cup

DOA-157-B1 Multi-Drug 5 Drugs Rapid Test 2- Step Cup Urine Cup

DOA- 167-B1 Multi-Drug 6 Drugs Rapid Test 2- Step Cup Urine Cup

DOA- 177- B1 Multi-Drug 7 Drugs Rapid Test 2- Step Cup Urine Cup

DOA- 187- B1 Multi-Drug 8 Drugs Rapid Test 2- Step Cup Urine Cup

DOA- 197- B1 Multi-Drug 9 Drugs Rapid Test 2-Step Cup Urine Cup
/
DOA-1107-B1 Multi-Drug 10 Drugs Rapid Test 2- Step Cup Urine Cup

DOA-1117-B1 Multi-Drug 11 Drugs Rapid Test 2- Step Cup Urine Cup

DOA-1127-B1 Multi-Orug 12 Drugs Rapid Test 2- Step Cup Urine Cup

DOA- 127- 82 Multi-Orug 2 Drugs Rapid Test 2- Step Cup Urine Cup
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www.hp<h.cl ílef. Nº 2%8/19
 ns to e
Salud Pública
l \l_nhterto de Salud

Gobierno de Chile

ANEXO CERTIFICADO
REVISIÓN DE ANTECEDENTES QUE ACOMPAÑAN AL DISPOSITIVO MÉDICO
Nº DOM/ 2146 / 19

DOA- 137- B2 Multi-Drug 3 Drugs Rapid Test 2- Step Cup Urine Cup

DOA- 147- B2 Multi-Drug 4 Drugs Rapid Test 2- Step Cup Urine Cup

DOA- 157- B2 Multi-Drug 5 Drugs Rapid Test 2- Step Cup Urine Cup

DOA- 167- B2 Multi-Drug 6 Drugs Rapid Test 2- Step Cup Urine Cup

DOA - 177- B2 Multi-Drug 7 Drugs Rapid Test 2- Step Cup Urine Cup

DOA- 187- B2 Multi-Drug 8 Drugs Rapid Test 2- Step Cup Urine Cup

DOA- 197- B2 Mult i-Drug 9 Drugs Rapid Test 2- Step Cup Urine Cup

DOA- 1107-B2 Multi-Drug 10 Drugs Rapid Test 2- Step Cup Urine Cup

DOA-1117-B2 Multi-Orug 11 Drugs Rapid Test 2- Step Cup Urine Cup

DOA-1127-B2 Multi- Drug 12 Drugs Rapid Test 2- Step Cup Urine Cup

DOA-1137-B2 Multi-Drug 13 Drugs Rapid Test 2-Step Cup Urine Cup /

DOA-1147 -B2 Multi-Drug 14 Drugs Rapid Test 2-Step Cup Urine Cup

DOA-1157-B2 Multi-Drug 15 Drugs Rapid Test 2-Step Cup Urine Cup

DOA-1167-B2 Multi-Orug 16 Drugs Rapid Test 2-Step Cup Urine Cup

OAL-801 Alcohol Rapid Test Dipstick Oral Fluid Dipstick 0.0002

DAL-802 Alcohol Rapid Test Cassette Oral Fluid Cassette 0.0002

DAM-802 Amphet amine CAMP) Rapid Test Cassette Oral Fluid Cassette 50 ng/ml
OAM-803 Amphetamine (AMP) Rapid Test Midstream Oral Fluid Midstream 50 ng/ml
o- f'yrrouamovateropnenone \o-f'Vf' ¡ 1<ap1a
OAP-802 Test Cassette Oral Fluid Cassette 300 ng/ml
o-t'yrro11amova1eropnenone (o- PV.- 11<ap1a
OAP-803 Test Midstream Oral Fluid Midstream 300 ng/ml
OBA-802 Barbiturates (BAR) Rapid Test Cassette Oral Fluid Cassette 50 ng/ml•
DBA- 803 Barbiturates (BAR) Rapid Test Midstream Oral Fluid Midstream 50 ng/mL•
DBU-802 Buprenorphine (BUP) Rapid Test Cassette Oral Fluid Cassette 10 ng/ml •
OBU-803 Buprenorphine(BUP) Rapid Test M idstream Oral Fluid Midstream 10 ng/mL •
DBZ-802 LU ng/ml, .JU
Benzodiazepines (BZO) Rapid Test Cassette Oral Fluid Cassette ng/ml
Jungm1L, :,u
DBZ-803 Benzodiazepines(BZO) Rapid Test Midstream Oral Fluid Midstream ng/ ml •
DC0-802 COCAINE ((OC) Rapid Test Cassette Oral Fluid Cassette 20 ng/ml
DC0-803 COCAINE (COC) Rapid Test Midstream Oral Fluid Midstream 20 ng/ml
DCFY-802 Carfentanyl(CFYU Rapid Test Cassette Oral Fluid Cassette 50 ng/ml
DCFY-803 Carfentanyl(CFYU Rapid Test Midstream Oral Fluid Miclstream 50 ng/ml
DCT-802 Cotinine (COTJ Rapid Test Cassette Ora( Fluid Cassette 20 ng/ml
DCT-803 Cotinine (COTJ Rapid Test Midstream Oral Fluid Miclstream 20 ng/ml

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www.h pch.cl Ref. Nº 2968/ 19
 Gobierno de Chile

ANEXO CERTIFICADO
REVISIÓN DE ANTECEDENTES QUE ACOMPAÑAN AL DISPOSITIVO MÉDICO
Nº DDM / 2146 / 19
_,...,,,º, 1\ '

DFY-802 Fentanyl (FYU Rapid Test Cassette Oral Fluid Cassette 20ng/ml
- - "C:t' n,

DFY-803 Fentanyl (FYU Rapid Test Midstream Oral Fluid Midstream 20ng/ml

DKE-802 Ketamine(KETl Rapid Test Cassette Oral Fluid Cassette 50 ng/ml•

DKE-803 Ketamine(KET) Rapid Test Midstream Oral Fluid Midstream 50 ng/ml*

b-Monoacetylmorpnme tb- MAMJ Kap1d I est
OMA- 802 Cassette Oral Fluid Cassette 10 ng/ml
b- Monoacetylmorpnme (b- MAMJ Kap1d test
DMA-803 Midstream Oral Fluid Midstream 10 ng/ml

OM0-802 Ecstasy (MOMA) Rapid Test Cassette Oral Fluid Cassette 50 ng/ml

OM0-803 Ecstasy (MOMA) Rapid Test Midstream Oral Fluid Midstream 50 ng/ml
Metnteneo1oxypyrovalerone lMUPV) Rap1d
DMDP- 802 Test assette Oral Fluid Cassette 300 ng/ml
Meth~ened10xypyrova1erone \MUf'VJKapId
OMOP-803 Test istream Oral Fluid Midstream 300 ng/ml

DME- 802 Methamphetamine (METI Rapid Test Cassette Oral Fluid Cassette 50 ng/ml
Methamphetamme \Mt I i Kap1d I est
OME- 803 Midstream Oral Fluid Midstream 50 ng/ml

OMT- 802 Methadone (MTO) Rapid Test Cassette Oral Fluid Cassette 30 ng/ml

DMT-803 Methadone (MTO) Rapid Test Midstream Oral Fluid Midstream 30 ng/ml

DOP-802 Opiates (OPll Rapid Test Cassette Oral Fluid Cassette 40 ng/ml

DOP-803 Opiates <OPll Rapid Test Midstream Oral Fluid Midstream 40 ng/ml

DOX-802 Oxycodone (OXYJ Rapid Test Cassette Oral Fluid Cassette 20 ng/ml

OOX- 803 Oxycodone (OXY) Rapid Test Midstream Oral Fluid Midstream 20 ng/ml

OPC-802 Phencyclidine (PCP) Rapid Test Cassette Oral Fluid Cassette 10 ng/ml

DPC-803 Phencyclidine (PCP) Rapid Test Midstream Oral Fluid Midstream 10 ng/ml

05M-802 5ynthetic Marijuana (K2) Rapid Test Cassette Oral Fluid Cassette 25 ng/ml

05M- 803 5ynthetic Marijuana (K2l Rapid Test Midstream Oral Fluid Midstream 25 ng/ml
lL ng/ml, LU
OTH- 802 Marijuana (THC) Rapid Test Cassette Oral Fluid Cassette ng/ml*
OTH-803 Marijuana (THC) Rapid Test Midstream Oral Fluid Midstream 50 ng/ml
OTM- 802 Tramadol<TMU Rapid Test Cassette Oral Fluid Cassette 30 ng/ml*

OTM- 803 Tramadol<TMU Rapid Test Midstream Oral Fluid Midstream 30 ng/ml*
050 -823-A Multi- Orug 2 Orugs Rapid Test Midstream Oral Fluid Midstream

050 -833-A Multi-Orug 3 Drugs Rapid Test Midstream Oral Fluid Midstream

050-843-A Multi- Orug 4 Orugs Rapid Test Midstream Oral Fluid Midstream

050-853-A Multi- Orug 5 Orugs Rapid Test Midstream Oral Fluid Midstream

050-863-A Multi-Orug 6 Orugs Rapid Test Midstream Oral Fluid Midstream /

050-873-A Multi-Orug 7 Drugs Rapid Test Midstream Oral Fluid Midstream

050-823-8 Multi-Drug 2 Orugs Rapid Test Midstream Oral Fluid Midstream

050-833-8 Multi-Orug 3 Orugs Rapid Test Midstream Oral Fluid Midstream

DSD-843-B Multi-Drug 4 Drugs Rapid Test Midstream Oral Fluid Midstream

050-853-8 Multi-Orug 5 Drugs Rapid Test Midstream Oral Fluid Midstream

05D-863-8 Multi- Drug 6 Drugs Rapid Test Midstream Oral Fluid Midstream
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www.lspch.cl Reí. Nº 2968/ 19
 Gobierno de Chile

ANEXO CERTIFICADO
REVISIÓN DE ANTECEDENTES QUE ACOMPAÑAN AL DISPOSITIVO MÉDICO
Nº DOM / 2146 / 19

D5D-873-B Multi-Drug 7 Drugs Rapid Test Midstream Oral Fluid Midstream

D5D-883-B Multi-Drug 8 Drugs Rapid Test Midstream Oral Fluid Midstream
/
DSD -893-B Multi-Drug 9 Drugs Rapid Test Midstream Oral Fluid Midstream
DSD-825-A Oral Fluid Multi-Drug 2 DrugsTest ACassette Oral Fluid Cassette
DSD-835- A Oral Fluid Multi-Drug 3 DrugsTestACassette Oral Fluid Cassette
DSD-845-A OralFluidMulti- Drug 4 Drugs Test ACassette Oral Fluid Cassette
DSD-855-A OralFluidMulti-Drug 5Drugs Test ACassette Oral Fluid Cassette
DSD-865-A Oral Fluid Mul ti-Drug 6D rugs TestACassette Oral Fluid Cassette
DSD-875-A Oral FluidMulti-Drug 7DrugsTestACassette Oral Fluid Cassette
/
DSD-885- A Oral Fluid Multi-Orug 8DrugsTest ACassette Oral Fluid Cassette
DSD-895-A Oral Fluid Multi- Drug 9DrugsTestACassette Oral Fluid Cassette
DSD-827 Multi-Drug 2 Drugs Rapid Test Cup Oral Fluid Cup
DSD-837 Multi- Drug 3 Drugs Rapid Test Cup Oral Fluid Cup
DSD-847 Multi-Drug 4 Drugs Rapid Test Cup Oral Fluid Cup
DSD-857 Multi-Drug 5 Drugs Rapid Test Cup Oral Fluid Cup
DSD-867 Multi-Drug 6 Drugs Rapid Test Cup Oral Fluid Cup

DSD -877 Multi-Drug 7 Drugs Rapid Test Cup Oral Fluid Cup

D5D-887 Multi- Drug 8 Drugs Rapid Test Cup Oral Fluid Cup

DSD-897 Multi- Drug 9 Drugs Rapid Test Cup Oral Fluid Cup
/
D5D-8107 Multi-Drug 10 Drugs Rapid Test Cup Oral Fluid Cup

D5D-8117 Multi-Drug 11 Drugs Rapid Test Cup Oral Fluid Cup

D5D-8127 Multi- Drug 12 Drugs Rapid Test Cup Oral Fluid Cup

DAC-X14 Acetaminophen CACE) Rapid Test Panel Powder Panel 5000 ng/ml

DAM- X14 Amphetamine CAMP) Rapid Test Panel Powder Panel 1000 ng/ml
o-r'yrro110Inovateropnenone 10-t'vt' J Hap10
OAP-X14 Test Panel Powder Panel 1000 ng/ml

OBA-X14 Barbiturate (BAR) Rapid Test Panel Powder Panel 300 ng/ml

DBU- X14 Buprenorphine (BUP) Rapid Test Panel Powder Panel 10 ng/ml

OBZ-X14 Benzodiazepines (BZOl Rapid Test Panel Powder Panel 300 ng/ml

OCO- X14 COCAINE (COO Rapid Test Panel Powder Panel 300 ng/ml

DCFY-X14 Carfentanyl(CFYU Rapid Test Panel Powder Panel 500 ng/ml

DCT- X14 Cotinine (COTJ Rapid Test Panel Powder Panel 200 ng/ml

00I- X14 Diazepam (DlA) Rapid Test Panel Powder Panel 300 ng/ml

OFY-X14 Fentanyl (FYU Rapid Test Panel Powder Panel 200 ng/ml

OKE- X14 Ketamine (KET)Rapid Test Panel Powder Panel 1000 ng/ml
llysergIc ACIO uIetnytamIoe ll)UJ HapI0 t est
DLS-X1 4 Panel Powder Panel 20 ng/ml
b-Monoace1ytmorpnme lb- MAMJHapI0 1est
DMA- X14 Panel Powder Panel 10 ng/ml

DMO- X14 Ecstasy (MOMA) Rapid Test Panel PowcJer Panel 500 ng/ml
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www.lspch.cl Ref. Nº 2966/ 19
 Gobierno de Chile

ANEXO CERTIFICADO
REVISIÓN DE ANTECEDENTES QUE ACOMPAÑAN AL DISPOSITIVO MÉDICO
Nº DOM / 2146 / 19

OMOA-X14 Tenamfetamine (MOA) Rapid Test Panel Powder Panel 500 ng/ml
1 Methteneaioxypyrovaterone \MDPVl Rap1d
OMOP-X14 Test anel Powder Panel 1000 ng/ml
OMP-X14 Methylphenidate(MPDl Rapid Test Panel Powder Panel 300 ng/ml
DME- X14 Methamphetamine (METl Rapid Test Panel Powder Panel 1000 ng/ml
OMO- X14 Morphine (MOPl Rapid Test Panel Powder Panel 300 ng/ml
OMQ-X14 Methaqualone (MQU Rapid Test Panel Powder Panel 300 ng/ml
OMT-X14 Methadone (MTO) Rapid Test Panel Powder Panel 300 ng/ml
DOX-X14 Oxycodone (OXYl Rapid Test Panel Powder Panel 100 ng/ml
□PC -X14 Phencycl idine (PCPl Rapid Test Panel Powder Panel 25 ng/mL
DPP-X14 Propoxyphene (PPXl Rapid Test Panel Powder Panel 300 ng/ml
DTC-X1 4 Tricyclic Antidepressants <TCAl Rapid Test Panel Powder Panel 1000 ng/ml
OTM- X14 Tramadol (TMU Rapid Test Panel Powder Panel 100 ng/ml
DZO-X14 Zolpidem(ZOU Rapid Test Panel Powder Panel 50 ng/ml

DOA-X24 Multi-Orug 2 Orugs Rapid Test Panel Powder Panel

DOA-X34 Multi-Orug 3 Orugs Rapid Test Panel Powder Panel

DOA-X44 Multi- Orug 4 Drugs Rapid Test Panel Powder Panel

DOA-X54 Multi-Orug 5 Orugs Rapid Test Panel Powder Panel

DOA-X64 Multi-Orug 6 Orugs Rapid Test Panel Powder Panel

OOA-X74 Multi-Orug 7 Orugs Rapid Test Panel Powder Panel

OOA-X84 Multi-Orug 8 Orugs Rapid Test Panel Powder Panel

OOA-X94 Multi- Orug 9 Drugs Rapid Test Panel Powder Panel

/
DOA-X104 Multi-Orug 10 Orugs Rapid Test Panel Powder Panel

DOA-X114 Multi-Orug 11 Orugs Rapid Test Panel Powder Panel

DOA-X124 Multi-Orug 12 Orugs Rapid Test Panel Powder Panel

OAM -402 AMP Rapid Test Cassette WB/5/P Cassette 80 ng/ml

OBA-402 BAR Rapid Test Cassette WB/5/P Cassette 100 ng/ml

OBU- 402 BUP Rapid Test Cassette WB/5/P Cassette 5 ng/ml

DBZ-402 azo Rapid Test Cassette WB/5/P Cassette 100 ng/ml

OC0-402 COC Rapid Test Cassette WB/5/P Cassette SO ng/ml

lU ngtmL,lUU
DCT-402 COT Rapid Test Cassette WB/5/P Cassette ng/ml•

EDOP Rapid Test Cassette WB/5/P Cassette SO ng/ml

DED-402
WB/5/P Cassette SO ng/ml
OM0- 402 MOMA Rapid Test Cassette
WB/5/P Cassette 70 ng/ml
OME-402 MET Rapid Test Cassette
WB/5/P Cassette 40 ng/ml
OM0-402 MOP Rapid Test Cassette
Cassette 40 ng/ml
OMT- 402 MTD Rapid Test Cassette WB/5/P
Cassette 20 ng/ml
DOX-402 OXY Rapid Test Cassette WB/5/P
Cassette 100 ng/ml
OPP- 402 PPX Rapid Test Cassette WB/5/P
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Página 12 de 13
www.lspch.cl Ref. Nº 2968/19
 Gobierno de Chile

ANEXO CERTIFICADO
REVISIÓN DE ANTECEDENTES QUE ACOMPAÑAN AL DISPOSITIVO MÉDICO
Nº DOM/ 2146 / 19

DTC-402 TCA Rapid Test Cassette WB/S/P Cassette 300 ng/mL

35 ng/ml*,50
DTH- 402 THC Rapid Test Cassette WB/S/P Cassette ng/ mL
DTM- 402 TML Rapid Test Cassette WB/S/P Cassette 50 ng/ml

DOA- 425 Multi-drug 2 drugs Test Cassette WB/S/P Cassette

DOA- 435 Multi- drug 3 drugs Test Cassette WB/S/P Cassette

OOA- 445 Multi-drug 4 drugs Test Cassette WB/S/P Cassette

DOA- 455 Multi- drug 5 drugs Test Cassette WB/S/P Cassette

DOA- 465 Multi- drug 6 drugs Test Cassette WB/S/P Cassette

DOA-475 Multi-drug 7 drugs Test Cassette WB/S/P Cassette

DOA- 485 Multi-drug 8 drugs Test Cassette WB/5/P Cassette

DOA- 495 Multi- drug 9 drugs Test Cassette WB/S/P Cassette

/
DOA- 4105 Multi- drug 10 drugs Test Cassette WB/5/P Cassette

DOA- 41 15 Multi- drug 11 drugs Test Cassette WB/5/P Cassette

'
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""~:Z-~ P AMENTO DISPOSITIVOS MÉDICOS
- - -e INSTITUTO DE SALUD PÚBLICA DE CHILE

Santiago, 12 de julio de 2019.

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Nº Ref.: 2968/19
Arch. 2146-19v Doc

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