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CA 15-3 AccuLite CLIA Kit - 96 wells

5675-300

IVD Class CIVDR 2017/746No longer on the marketKitProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870022178
Basic UDI-DI: 081687002CA1535675S4
Reference: 5675-300A
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 21.09.2026 21:52

Manufacturer products Authorised representative products Authorised representative actors View details

CA 15-3 AccuLite CLIA Kit - 192 wells

IVD generalIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870022185
Basic UDI-DI: B-00816870022185
Reference: 5675-300B
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: -
Authorised representative: AR Experts B.V.
Last updated: 21.09.2026 21:52

Manufacturer products Authorised representative products Authorised representative actors View details

CA 19-9 AccuBind ELISA Kit - 96 wells

3925-300

IVD Class CIVDR 2017/746No longer on the marketKitProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870020518
Basic UDI-DI: 081687002CA1993925VC
Reference: 3925-300A
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 21.09.2026 21:42

Manufacturer products Authorised representative products Authorised representative actors View details

CA 19-9 AccuBind ELISA Kit - 192 wells

IVD Class CIVDR 2017/746No longer on the marketKitProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870020525
Basic UDI-DI: 081687002CA1993925VC
Reference: 3925-300B
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: -
Authorised representative: AR Experts B.V.
Last updated: 21.09.2026 21:42

Manufacturer products Authorised representative products Authorised representative actors View details

CA 19-9 AccuLite CLIA Kit - 96 wells

3975-300

IVD Class CIVDR 2017/746No longer on the marketKitProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870022192
Basic UDI-DI: 081687002CA1993975VT
Reference: 3975-300A
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 21.09.2026 21:42

Manufacturer products Authorised representative products Authorised representative actors View details

CA 19-9 AccuLite CLIA Kit - 192 wells

3975-300

IVD Class CIVDR 2017/746No longer on the marketKitProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870022208
Basic UDI-DI: 081687002CA1993975VT
Reference: 3975-300B
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 21.09.2026 21:42

Manufacturer products Authorised representative products Authorised representative actors View details

Prostate Specific Antigen Test Kit (FIA)

VID24

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339211453
Basic UDI-DI: 697022176VID2400001A3
Reference: VID24-06-011
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 21.09.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details

Carcinoembryonic antigen (CEA) Test Kit (Homogeneous Chemiluminescence Immunoassay)

Carcinoembryonic Antigen (CEA) Test Kit (Homogeneous Chemiluminescence Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Poclight Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000039609
UDI-DI: 06974524062353
Basic UDI-DI: B-06974524062353
Reference: HCLIA15138
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 21.09.2026 21:00

Manufacturer products Authorised representative products Authorised representative actors View details

Cytokeratin 19 Fragment 21-1 (CYFRA21-1) Test Kit (Homogeneous Chemiluminescence Immunoassay)

Cytokeratin19 Fragment21-1 (CYFRA21-1) Test Kit (Homogeneous Chemiluminescence Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Poclight Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000039609
UDI-DI: 06974524062377
Basic UDI-DI: B-06974524062377
Reference: HCLIA15140
EMDN: W0102030126
EMDN description: CYTOKERATINS
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 21.09.2026 21:00

Manufacturer products Authorised representative products Authorised representative actors View details

Free Prostate Specific Antigen Detection Kit ( Chemiluminescence Immunoassay )

14 packaging specifications

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

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202220951
Basic UDI-DI: 69422022W010203011401R07S
Reference: 3023737
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 21.09.2026 17:44

Manufacturer products Authorised representative products Authorised representative actors View details

Total Prostate Specific Antigen Detection Kit ( Chemiluminescence Immunoassay )

14 packaging specifications

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

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202220814
Basic UDI-DI: 69422022W010203011301R07F
Reference: 3023667
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 21.09.2026 17:44

Manufacturer products Authorised representative products Authorised representative actors View details

Bladder Tumor Antigen Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-TBT-102(AT)GW
Basic UDI-DI: B-TBT-102(AT)GW
Reference: TBT-102
EMDN: W0102030101
EMDN description: BLADDER TUMOUR ANTIGEN
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:33

Manufacturer products Authorised representative products Authorised representative actors View details

Total Prostate Specific Antigen Detection Kit ( Chemiluminescence Immunoassay )

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

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202220821
Basic UDI-DI: 69422022W010203011301R07F
Reference: 3023735
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 21.09.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

Total Prostate Specific Antigen Detection Kit ( Chemiluminescence Immunoassay )

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

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202220838
Basic UDI-DI: 69422022W010203011301R07F
Reference: 3023668
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 21.09.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

Total Prostate Specific Antigen Detection Kit ( Chemiluminescence Immunoassay )

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

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202220845
Basic UDI-DI: 69422022W010203011301R07F
Reference: 3024017
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 21.09.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

Total Prostate Specific Antigen Detection Kit ( Chemiluminescence Immunoassay )

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

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202220852
Basic UDI-DI: 69422022W010203011301R07F
Reference: 3023669
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 21.09.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

Total Prostate Specific Antigen Detection Kit ( Chemiluminescence Immunoassay )

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

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202220876
Basic UDI-DI: 69422022W010203011301R07F
Reference: 3027671
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 21.09.2026 17:30

Manufacturer products Authorised representative products Authorised representative actors View details

Total Prostate Specific Antigen Detection Kit ( Chemiluminescence Immunoassay )

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

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202220883
Basic UDI-DI: 69422022W010203011301R07F
Reference: 3023817
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 21.09.2026 17:30

Manufacturer products Authorised representative products Authorised representative actors View details

Total Prostate Specific Antigen Detection Kit ( Chemiluminescence Immunoassay )

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

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202220890
Basic UDI-DI: 69422022W010203011301R07F
Reference: 3023606
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 21.09.2026 17:30

Manufacturer products Authorised representative products Authorised representative actors View details

Total Prostate Specific Antigen Detection Kit ( Chemiluminescence Immunoassay )

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

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202220906
Basic UDI-DI: 69422022W010203011301R07F
Reference: 3023736
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 21.09.2026 17:30

Manufacturer products Authorised representative products Authorised representative actors View details