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OraQuick HIV Self-Test

1001-0630U

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337001068
Basic UDI-DI: B-00608337001068
Reference: 1001-0630U
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Czechia
Authorised representative: QbD RepS BV
Last updated: 01.08.2026 10:01

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HIV Self-Test

1001-0627U

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337001662
Basic UDI-DI: B-00608337001662
Reference: 1001-0627U
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Bulgaria
Authorised representative: QbD RepS BV
Last updated: 01.08.2026 10:01

Manufacturer products Authorised representative products Authorised representative actors View details

AmoyDx® AutoExtract Kit (Whole Blood DNA)

48 tests/kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Amoy Diagnostics Co., LTD.
Manufacturer SRN: CN-MF-000021843
UDI-DI: 06959094215026
Basic UDI-DI: 69590942A0040GC
Reference: 8.02.0152
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:04

Manufacturer products Authorised representative products Authorised representative actors View details

AmoyDx® AutoExtract Kit (FFPE RNA)

48 tests/kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Amoy Diagnostics Co., LTD.
Manufacturer SRN: CN-MF-000021843
UDI-DI: 06959094215019
Basic UDI-DI: 69590942A0039GT
Reference: 8.02.0151
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:04

Manufacturer products Authorised representative products Authorised representative actors View details

B19 IgM CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359552516
Basic UDI-DI: 697015090000276HT
Reference: CMK1205
EMDN: W0105040609
EMDN description: PARVOVIRUS B 19
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:04

Manufacturer products Authorised representative products Authorised representative actors View details

B19 IgG CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359552417
Basic UDI-DI: 697015090000275HR
Reference: CMK1105
EMDN: W0105040609
EMDN description: PARVOVIRUS B 19
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:04

Manufacturer products Authorised representative products Authorised representative actors View details

ProGRP CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359550413
Basic UDI-DI: 697015090000228HG
Reference: CMB1905
EMDN: W0102030121
EMDN description: PRO-GASTRIN-RELEASING PEPTIDE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:04

Manufacturer products Authorised representative products Authorised representative actors View details

HE4 CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359550314
Basic UDI-DI: 697015090000227HE
Reference: CMB1805
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:04

Manufacturer products Authorised representative products Authorised representative actors View details

G-17 CLIA Microparticles

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359550215
Basic UDI-DI: 697015090000231H5
Reference: CMB2105
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:04

Manufacturer products Authorised representative products Authorised representative actors View details

PepsinogenⅡ CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359550116
Basic UDI-DI: 697015090000230H3
Reference: CMB1605
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:04

Manufacturer products Authorised representative products Authorised representative actors View details

PepsinogenⅠ CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359550017
Basic UDI-DI: 697015090000229HJ
Reference: CMB1505
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:04

Manufacturer products Authorised representative products Authorised representative actors View details

CYFRA 21-1 CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359549912
Basic UDI-DI: 697015090000226HC
Reference: CMB1205
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:04

Manufacturer products Authorised representative products Authorised representative actors View details

CA50 CLIA Microparticles

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359549813
Basic UDI-DI: 697015090000225HA
Reference: CMB0405
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:04

Manufacturer products Authorised representative products Authorised representative actors View details

PIVKA-Ⅱ CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359549691
Basic UDI-DI: 697015090000083HE
Reference: CMB2003
EMDN: W0102039017
EMDN description: PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:03

Manufacturer products Authorised representative products Authorised representative actors View details

CA19-9 CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359549592
Basic UDI-DI: 697015090000010GK
Reference: CMB0803
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:03

Manufacturer products Authorised representative products Authorised representative actors View details

CA242 CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359549493
Basic UDI-DI: 697015090000016GX
Reference: CMB1703
EMDN: W0102030108
EMDN description: CANCER ANTIGEN 242
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:03

Manufacturer products Authorised representative products Authorised representative actors View details

CA72-4 CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359549394
Basic UDI-DI: 697015090000015GV
Reference: CMB1403
EMDN: W0102030105
EMDN description: CANCER ANTIGEN 72-4
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:03

Manufacturer products Authorised representative products Authorised representative actors View details

CA15-3 CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359549318
Basic UDI-DI: 697015090000009H2
Reference: CMB0705
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:03

Manufacturer products Authorised representative products Authorised representative actors View details

SCCA CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359549196
Basic UDI-DI: 697015090000014GT
Reference: CMB1303
EMDN: W0102030116
EMDN description: SQUAMOUS CELL CARCINOMA ANTIGEN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:03

Manufacturer products Authorised representative products Authorised representative actors View details

HS-cTnT CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359548311
Basic UDI-DI: 697015090000260HC
Reference: CMH0605
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:03

Manufacturer products Authorised representative products Authorised representative actors View details