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646 device results listed.

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HE4 CLIA Microparticles

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359550291
Basic UDI-DI: 697015090000227HE
Reference: CMB1803
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:51

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G-17 CLIA Microparticles

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359550192
Basic UDI-DI: 697015090000231H5
Reference: CMB2103
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:51

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PepsinogenⅡ CLIA Microparticles

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359550093
Basic UDI-DI: 697015090000230H3
Reference: CMB1603
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:51

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PepsinogenⅠ CLIA Microparticles

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359549998
Basic UDI-DI: 697015090000229HJ
Reference: CMB1503
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:51

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CYFRA 21-1 CLIA Microparticles

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359549899
Basic UDI-DI: 697015090000226HC
Reference: CMB1203
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:51

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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: 06942359549790
Basic UDI-DI: 697015090000225HA
Reference: CMB0403
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:51

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CA15-3 CLIA Microparticles

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359549295
Basic UDI-DI: 697015090000009H2
Reference: CMB0703
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:51

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β2-Microglobulin CLIA Microparticles

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IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359549097
Basic UDI-DI: 697015090000012GP
Reference: CMB1003
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

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Ferritin CLIA Microparticles

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359548991
Basic UDI-DI: 697015090000011GM
Reference: CMB0903
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

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AFP CLIA Microparticles

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359548892
Basic UDI-DI: 697015090000006GU
Reference: CMB0103
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

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NSE CLIA Microparticles

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359548793
Basic UDI-DI: 697015090000013GR
Reference: CMB1103
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

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CEA CLIA Microparticles

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359548595
Basic UDI-DI: 697015090000007GW
Reference: CMB0203
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

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fPSA CLIA Microparticles

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359548496
Basic UDI-DI: 697015090000112GU
Reference: CMB0503
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

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tPSA CLIA Microparticles

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359548397
Basic UDI-DI: 697015090000111GS
Reference: CMB0303
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

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HS-cTnT CLIA Microparticles

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359548298
Basic UDI-DI: 697015090000260HC
Reference: CMH0603
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

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H-FABP CLIA Microparticles

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359548199
Basic UDI-DI: 697015090000259HT
Reference: CMH1103
EMDN: W01021302
EMDN description: HEART-TYPE FATTY ACID BINDING PROTEIN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

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NT-proBNP CLIA Microparticles

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IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359548090
Basic UDI-DI: 697015090000038H9
Reference: CMH0403
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB CLIA Microparticles

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359547994
Basic UDI-DI: 697015090000037H7
Reference: CMH0303
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

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PCT CLIA Microparticles

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359547895
Basic UDI-DI: 697015090000043H2
Reference: CMR0203
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

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BNP CLIA Microparticles

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IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359547796
Basic UDI-DI: 697015090000082HC
Reference: CMH0803
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

Manufacturer products Authorised representative products Authorised representative actors View details