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227 device results listed.

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EliA ß2-Glycoprotein I IgG Well

EliA β2-Glycoprotein I IgG

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

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066014753
Basic UDI-DI: 7333066BUDI0096MM
Reference: 14-5532-01
EMDN: W0102100503
EMDN description: ANTI-B2-GLYCOPROTEIN I ANTIBODIES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:16

Manufacturer products View details

EliA ß2-Glycoprotein I IgA Well

EliA β2-Glycoprotein I IgA

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

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066014746
Basic UDI-DI: 7333066BUDI0095MK
Reference: 14-5531-01
EMDN: W0102100503
EMDN description: ANTI-B2-GLYCOPROTEIN I ANTIBODIES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:16

Manufacturer products View details

EliA Cardiolipin IgM Well

EliA Cardiolipin IgM

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066014739
Basic UDI-DI: 7333066BUDI0094MH
Reference: 14-5530-01
EMDN: W0102100501
EMDN description: ANTI-CARDIOLIPIN ANTIBODIES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:16

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EliA Cardiolipin IgG Well

EliA Cardiolipin IgG

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066014722
Basic UDI-DI: 7333066BUDI0093MF
Reference: 14-5529-01
EMDN: W0102100501
EMDN description: ANTI-CARDIOLIPIN ANTIBODIES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:16

Manufacturer products View details

EliA Cardiolipin IgA Well

EliA Cardiolipin IgA

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066014715
Basic UDI-DI: 7333066BUDI0092MD
Reference: 14-5528-01
EMDN: W0102100501
EMDN description: ANTI-CARDIOLIPIN ANTIBODIES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:16

Manufacturer products View details

Anti-β2-GP1 IgA 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: 06942359514132
Basic UDI-DI: 697015090000322H9
Reference: CMQ3010
EMDN: W0102100503
EMDN description: ANTI-B2-GLYCOPROTEIN I ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 26.06.2026 19:51

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-β2-GP1 IgA 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: 06942359514118
Basic UDI-DI: 697015090000322H9
Reference: CMQ3008
EMDN: W0102100503
EMDN description: ANTI-B2-GLYCOPROTEIN I ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 26.06.2026 19:51

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-β2-GP1 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: 06942359514026
Basic UDI-DI: 697015090000321H7
Reference: CMQ2910
EMDN: W0102100503
EMDN description: ANTI-B2-GLYCOPROTEIN I ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 26.06.2026 19:51

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-β2-GP1 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: 06942359514002
Basic UDI-DI: 697015090000321H7
Reference: CMQ2908
EMDN: W0102100503
EMDN description: ANTI-B2-GLYCOPROTEIN I ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 26.06.2026 19:51

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-beta 2 Glycoprotein 1 Antibody IgA/G/M (β2-GP1-IgA/G/M) Assay Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028502200
Basic UDI-DI: B-06942028502200
Reference: DB2001
EMDN: W0102100503
EMDN description: ANTI-B2-GLYCOPROTEIN I ANTIBODIES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 03:16

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-cardiolipin antibody IgA/G/M (aCL-A/G/M) Assay Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028502040
Basic UDI-DI: B-06942028502040
Reference: DB1601
EMDN: W0102100501
EMDN description: ANTI-CARDIOLIPIN ANTIBODIES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 03:16

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiolipin/ ß2-GPI IgG Dot

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023687055
Basic UDI-DI: 542502368BDAPS2U
Reference: AD CBGD
EMDN: W0102100599
EMDN description: ANTI-PHOSPHOLIP SYNDROME - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:23

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Cardiolipin/β2- GPI IgG for BDI

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023687352
Basic UDI-DI: 542502368BDDAPSZQ
Reference: AD CBGDBD
EMDN: W0102100599
EMDN description: ANTI-PHOSPHOLIP SYNDROME - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:23

Manufacturer products View details

DIASpot Neptune APS IgG

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023688151
Basic UDI-DI: 542502368BDDAPSZQ
Reference: KAPDTAPSGN
EMDN: W0102100599
EMDN description: ANTI-PHOSPHOLIP SYNDROME - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:23

Manufacturer products View details

Anti-aPS/PT IgM CLIA Assay Kit