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Buprenorphine Enzyme Immunoassay

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: Lin-Zhi International, Inc.
Manufacturer SRN: US-MF-000003373
UDI-DI: 00850624008018
Basic UDI-DI: 0850624008EIABUP02C9
Reference: 08362955190
EMDN: W0102090117
EMDN description: BUPRENORPHINE
First on market country: France
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 06:33

Manufacturer products Authorised representative products Authorised representative actors View details

6-Acetylmorphine Enzyme Immunoassay

08240035190

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: Lin-Zhi International, Inc.
Manufacturer SRN: US-MF-000003373
UDI-DI: 00850624008001
Basic UDI-DI: 0850624008EIA6AM023M
Reference: 08240035190
EMDN: W0102090116
EMDN description: 6-ACETHYLMORPHIUM
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 06:33

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Ethyl Alcohol (ETOH)

IVDR_67_TTN_DUB-C_B_REAG_ETOH

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596112
Basic UDI-DI: 0405686901708VV
Reference: 11097501
EMDN: W0102090207
EMDN description: ETHANOL (ALCOHOL)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Opiates (Op)

IVDR_67_TTN_DUB-C_B_REAG_OP_2

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596105
Basic UDI-DI: 0405686901753W2
Reference: 11097502
EMDN: W0102090113
EMDN description: OPIATES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Cannabinoids THC (Thc)

IVDR_67_TTN_DUB-C_B_REAG_THC_2

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596099
Basic UDI-DI: 0405686901774WA
Reference: 11097503
EMDN: W0102090105
EMDN description: CANNABINOIDS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Cocaine Metabolite (Coc)

IVDR_67_TTN_DUB-C_B_REAG_Cocaine Metabolite

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596082
Basic UDI-DI: 0405686901687WE
Reference: 11097504
EMDN: W0102090106
EMDN description: COCAINE + COCAINE METABOLITES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Benzodiazepines (Bnz)

IVDR_67_TTN_DUB-C_B_REAG_BENZ_2

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596075
Basic UDI-DI: 0405686901668WA
Reference: 11097505
EMDN: W0102090104
EMDN description: BENZODIAZEPINES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Barbiturates (Brb)

IVDR_67_TTN_DUB-C_B_REAG_BARB_2

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596051
Basic UDI-DI: 0405686901667W8
Reference: 11097507
EMDN: W0102090103
EMDN description: BARBITURATES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Phencyclidine (Pcp)

IVDR_67_TTN_DUB-C_B_REAG_PCP_2

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596044
Basic UDI-DI: 0405686901757WA
Reference: 11097509
EMDN: W0102090114
EMDN description: PHENCYCLIDINE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Ecstasy (Xtc)

IVDR_67_TTN_DUB-C_B_REAG_Ecstasy

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414595955
Basic UDI-DI: 0405686901700VD
Reference: 11097518
EMDN: W0102090102
EMDN description: AMPHETAMINE/METHAMPHETAMINE SPECIFIC
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Propoxyphene (Ppx)

IVDR_67_TTN_DUB-C_B_REAG_PPX_2

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414595948
Basic UDI-DI: 0405686901764W7
Reference: 11097519
EMDN: W0102090115
EMDN description: PROPOXYPHENE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Methadone (Mdn)

IVDR_67_TTN_DUB-C_B_REAG_MDN

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414595917
Basic UDI-DI: 0405686901746W5
Reference: 11097520
EMDN: W0102090110
EMDN description: METHADONE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Oxycodone (OXY)

IVDR_67_TTN_DUB-C_B_REAG_OXY

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414238098
Basic UDI-DI: 0405686901754W4
Reference: 11097541
EMDN: W0102090123
EMDN description: OXYCODINE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

Emit® II Plus Ecstasy Assay

IVDR_67_GLA_DUB-C_B_REAG_Ecstasy Assay

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768023460
Basic UDI-DI: 0405686901098VM
Reference: 10445479
EMDN: W0102090102
EMDN description: AMPHETAMINE/METHAMPHETAMINE SPECIFIC
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Emit® II Plus Ethyl Alcohol Assay

IVDR_67_GLA_DUB-C_B_REAG_Ethyl Alcohol Assay

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768023439
Basic UDI-DI: 0405686901107UV
Reference: 10445451
EMDN: W0102090207
EMDN description: ETHANOL (ALCOHOL)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Emit® II Plus Cocaine Metabolite Assay

IVDR_67_GLA_DUB-C_B_REAG_Cocaine Metabolite Assay

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768023415
Basic UDI-DI: 0405686901088VJ
Reference: 10445440
EMDN: W0102090106
EMDN description: COCAINE + COCAINE METABOLITES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Emit® II Plus Benzodiazepine Assay

IVDR_67_GLA_DUB-C_B_REAG_Benzodiazepine Assay

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768023392
Basic UDI-DI: 0405686901066V8
Reference: 10445432
EMDN: W0102090104
EMDN description: BENZODIAZEPINES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Emit® II Plus Barbiturate Assay

IVDR_67_GLA_DUB-C_B_REAG_Barbiturate Assay

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768023378
Basic UDI-DI: 0405686901064V4
Reference: 10445425
EMDN: W0102090103
EMDN description: BARBITURATES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Emit® tox™ Acetaminophen Assay

IVDR_67_GLA_DUB-C_C_REAG_Acetaminophen Assay

IVD Class CIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768023330
Basic UDI-DI: 0405686901227V8
Reference: 10445384
EMDN: W0102090201
EMDN description: ACETAMINOPHENE (PARACETAMOL)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II LSD Assay

IVDR_67_GLA_DUB-C_B_REAG_LSD Assay

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768020315
Basic UDI-DI: 0405686901141UV
Reference: 10445455
EMDN: W0102090109
EMDN description: LYSERGIC ACID DIETHYLAMIDE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details