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AutoLumo HER-2/neu 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: 06942359521642
Basic UDI-DI: 697015090000132H2
Reference: CA062201
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:48

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AutoLumo β-CTX Calibrators

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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: 06942359521604
Basic UDI-DI: 697015090000137HC
Reference: CA220201
EMDN: W0102152202
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:48

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AutoLumo PINP Calibrators

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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: 06942359521567
Basic UDI-DI: 697015090000139HG
Reference: CA220101
EMDN: W0102152202
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:48

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Autoimmune Maker Control I

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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: 06942359520560
Basic UDI-DI: 697015090000127H9
Reference: ZKE010101
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:48

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PIVKA-II 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: 06942359517218
Basic UDI-DI: 697015090000083HE
Reference: CMB2007
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 20:48

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CA242 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: 06942359517164
Basic UDI-DI: 697015090000016GX
Reference: CMB1707
EMDN: W0102030108
EMDN description: CANCER ANTIGEN 242
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:48

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CA72-4 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: 06942359517119
Basic UDI-DI: 697015090000015GV
Reference: CMB1407
EMDN: W0102030105
EMDN description: CANCER ANTIGEN 72-4
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:48

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SCCA 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: 06942359517065
Basic UDI-DI: 697015090000014GT
Reference: CMB1307
EMDN: W0102030116
EMDN description: SQUAMOUS CELL CARCINOMA ANTIGEN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:48

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CA19-9 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: 06942359516860
Basic UDI-DI: 697015090000010GK
Reference: CMB0807
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:48

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CA125 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: 06942359516754
Basic UDI-DI: 697015090000008GY
Reference: CMB0606
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:48

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Anti-CCP IgG 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: 06942359515603
Basic UDI-DI: 697015090000116H4
Reference: CMQ1401
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:48

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RF IgM 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: 06942359515528
Basic UDI-DI: 697015090000302H3
Reference: CMQ1101
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:48

Manufacturer products Authorised representative products Authorised representative actors View details

Preservation

IVD Class AIVDR 2017/746On the marketAnimal tissuesHuman tissues

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359515467
Basic UDI-DI: 697015090000369J3
Reference: CMO0901
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:48

Manufacturer products Authorised representative products Authorised representative actors View details

Gram Negative bacteria ID

Automated Microbiology System Analyzers

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359515061
Basic UDI-DI: 697015090000332HC
Reference: ME0601
EMDN: W0104080101
EMDN description: GRAM NEGATIVE IDENTIFICATION - AUTOMATED
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:48

Manufacturer products Authorised representative products Authorised representative actors View details

Gram Positive bacteria ID

Automated Microbiology System Analyzers

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359515009
Basic UDI-DI: 697015090000331HA
Reference: ME0501
EMDN: W0104080103
EMDN description: GRAM POSITIVE IDENTIFICATION - AUTOMATED
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:48

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Anti-CL IgA 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: 06942359514958
Basic UDI-DI: 697015090000330H8
Reference: CMQ3708
EMDN: W0102100501
EMDN description: ANTI-CARDIOLIPIN ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:47

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Anti-CL IgM 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: 06942359514842
Basic UDI-DI: 697015090000329HP
Reference: CMQ3608
EMDN: W0102100501
EMDN description: ANTI-CARDIOLIPIN ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:47

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-CL IgG 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: 06942359514736
Basic UDI-DI: 697015090000328HM
Reference: CMQ3508
EMDN: W0102100501
EMDN description: ANTI-CARDIOLIPIN ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:47

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-CL 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: 06942359514620
Basic UDI-DI: 697015090000327HK
Reference: CMQ3408
EMDN: W0102100501
EMDN description: ANTI-CARDIOLIPIN ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:47

Manufacturer products Authorised representative products Authorised representative actors View details

ANA IgG 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: 06942359514453
Basic UDI-DI: 697015090000326HH
Reference: CMQ3301
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:47

Manufacturer products Authorised representative products Authorised representative actors View details