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646 device results listed.

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Anti-Ro-52 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: 06942359544764
Basic UDI-DI: 697015090000306HB
Reference: CMQ0803
EMDN: W0102100112
EMDN description: SS-A
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

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Anti-SS-A/Ro 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: 06942359544665
Basic UDI-DI: 697015090000305H9
Reference: CMQ0703
EMDN: W0102100112
EMDN description: SS-A
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

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RF IgA 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: 06942359544566
Basic UDI-DI: 697015090000304H7
Reference: CMQ1303
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

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RF 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: 06942359544467
Basic UDI-DI: 697015090000303H5
Reference: CMQ1203
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

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RF 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: 06942359544269
Basic UDI-DI: 697015090000301GZ
Reference: CMQ1003
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

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SHBG 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: 06942359543866
Basic UDI-DI: 697015090000033GX
Reference: CMF0803
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

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C-Peptide 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: 06942359543460
Basic UDI-DI: 697015090000073HB
Reference: CMG0203
EMDN: W0102060101
EMDN description: C-PEPTIDE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

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Insulin 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: 06942359543361
Basic UDI-DI: 697015090000072H9
Reference: CMG0103
EMDN: W0102060103
EMDN description: INSULIN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

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DHEA-S 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: 06942359543767
Basic UDI-DI: 697015090000032GV
Reference: CMF0703
EMDN: W0102050102
EMDN description: DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

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17α-OHP 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: 06942359543668
Basic UDI-DI: 697015090000034GZ
Reference: CMF0903
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

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FSH 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: 06942359543187
Basic UDI-DI: 697015090000027H4
Reference: CMF0205
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

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LH 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: 06942359543088
Basic UDI-DI: 697015090000026H2
Reference: CMF0105
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

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Testosterone 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: 06942359542982
Basic UDI-DI: 697015090000029H8
Reference: CMF0405
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

PRG 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: 06942359542883
Basic UDI-DI: 697015090000031GT
Reference: CMF0605
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

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E2 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: 06942359542784
Basic UDI-DI: 697015090000030GR
Reference: CMF0505
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

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25-OH Vitamin D 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: 06942359542364
Basic UDI-DI: 697015090000075HF
Reference: CMS0403
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

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Calcitonin 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: 06942359542463
Basic UDI-DI: 697015090000048HC
Reference: CMS0603
EMDN: W0102060301
EMDN description: CALCITONIN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

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Osteocalcin 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: 06942359542265
Basic UDI-DI: 697015090000045H6
Reference: CMS0103
EMDN: W0102060311
EMDN description: OSTEOCALCINE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

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PTH 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: 06942359542166
Basic UDI-DI: 697015090000025GY
Reference: CME0903
EMDN: W01020499
EMDN description: THYROID HORMONES - OTHER
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

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TG 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: 06942359542067
Basic UDI-DI: 697015090000024GW
Reference: CME0803
EMDN: W01020408
EMDN description: THYROGLOBULIN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details