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23 device results listed.

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BlueDiverDot APS IgG

BlueDiverDot APS

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681367
Basic UDI-DI: 542502368BDDAPSZQ
Reference: APSGDIV-24
EMDN: W0102100599
EMDN description: ANTI-PHOSPHOLIP SYNDROME - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

Manufacturer products View details

BlueDot APS IgG

BlueDot APS

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680360
Basic UDI-DI: 542502368BDAPS2U
Reference: APSGD-24
EMDN: W0102100599
EMDN description: ANTI-PHOSPHOLIP SYNDROME - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

Manufacturer products View details

D-R994496T

N/A

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Manufacturer SRN: AT-MF-000000254
UDI-DI: D-R994496T
Basic UDI-DI: B-R994496T
Reference: R99449
EMDN: W0102100599
EMDN description: ANTI-PHOSPHOLIP SYNDROME - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 15.07.2026 05:25

Manufacturer products View details

Anti-Phospholipid Screen IgM

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147194758
Basic UDI-DI: B-86060147194758
Reference: N252A24PHM
EMDN: W0102100599
EMDN description: ANTI-PHOSPHOLIP SYNDROME - OTHER
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:14

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Phospholipid Screen IgG

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147194680
Basic UDI-DI: B-86060147194680
Reference: N251A24PHG
EMDN: W0102100599
EMDN description: ANTI-PHOSPHOLIP SYNDROME - OTHER
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:14

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Phospholipid Screen

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147182014
Basic UDI-DI: B-86060147182014
Reference: N2511A24PH
EMDN: W0102100599
EMDN description: ANTI-PHOSPHOLIP SYNDROME - OTHER
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:13

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay APS IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06980070460062
Basic UDI-DI: B-06980070460062
Reference: 14000781
EMDN: W0102100599
EMDN description: ANTI-PHOSPHOLIP SYNDROME - OTHER
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 07.07.2026 02:53

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-PCNA Antibody CLIA Assay Kit

100 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424226531
Basic UDI-DI: B-06975424226531
Reference: CL20352EN
EMDN: W0102100599
EMDN description: ANTI-PHOSPHOLIP SYNDROME - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-PCNA Antibody CLIA Assay Kit

100 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424224001
Basic UDI-DI: B-06975424224001
Reference: CL30352EN
EMDN: W0102100599
EMDN description: ANTI-PHOSPHOLIP SYNDROME - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-PCNA Antibody CLIA Assay Kit

100 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424220096
Basic UDI-DI: B-06975424220096
Reference: 100 tests/kit
EMDN: W0102100599
EMDN description: ANTI-PHOSPHOLIP SYNDROME - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay APS IgM (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070769833
Basic UDI-DI: B-06975070769833
Reference: 14000782
EMDN: W0102100599
EMDN description: ANTI-PHOSPHOLIP SYNDROME - OTHER
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:52

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-Phospholipid Syndrome Antibody Profile IgG (CLIA)

18516001

IVD generalIVDDNo longer on the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070762353
Basic UDI-DI: B-06975070762353
Reference: 18516001
EMDN: W0102100599
EMDN description: ANTI-PHOSPHOLIP SYNDROME - OTHER
First on market country: -
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:37

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-Phospholipid Syndrome Antibody Profile IgG (CLIA)

100 Tests/kit

IVD generalIVDDNo longer on the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070762346
Basic UDI-DI: B-06975070762346
Reference: 18515001
EMDN: W0102100599
EMDN description: ANTI-PHOSPHOLIP SYNDROME - OTHER
First on market country: -
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:37

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-Phospholipid Syndrome Antibody Profile IgG (CLIA)

100 Tests/kit

IVD generalIVDDNo longer on the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle useSterile

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070762339
Basic UDI-DI: B-06975070762339
Reference: 18514001
EMDN: W0102100599
EMDN description: ANTI-PHOSPHOLIP SYNDROME - OTHER
First on market country: -
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:37

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-Phospholipid Syndrome Antibody Profile IgG (CLIA)

100 Tests/kit

IVD generalIVDDNo longer on the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070762322
Basic UDI-DI: B-06975070762322
Reference: 18513001
EMDN: W0102100599
EMDN description: ANTI-PHOSPHOLIP SYNDROME - OTHER
First on market country: -
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:37

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-Phospholipid Syndrome Antibody Profile IgG (CLIA)

100 Tests/kit

IVD generalIVDDNo longer on the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070762315
Basic UDI-DI: B-06975070762315
Reference: 18512001
EMDN: W0102100599
EMDN description: ANTI-PHOSPHOLIP SYNDROME - OTHER
First on market country: -
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:37

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-Phospholipid Syndrome Antibody Profile IgG (CLIA)

100 Tests/kit

IVD generalIVDDNo longer on the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070762308
Basic UDI-DI: B-06975070762308
Reference: 18511001
EMDN: W0102100599
EMDN description: ANTI-PHOSPHOLIP SYNDROME - OTHER
First on market country: -
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:37

Manufacturer products Authorised representative products Authorised representative actors View details

PHOSPHO-LISA IgG &IgM

PHOSPHO-LISA IgG and IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672001322
Basic UDI-DI: B-03532672001322
Reference: HM 007PE
EMDN: W0102100599
EMDN description: ANTI-PHOSPHOLIP SYNDROME - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:42

Manufacturer products View details

08034049111146

Anti Phospholipid Screen

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Dia.Metra Srl
Manufacturer SRN: IT-MF-000027206
UDI-DI: 08034049111146
Basic UDI-DI: 8034049111146UT
Reference: DKO114
EMDN: W0102100599
EMDN description: ANTI-PHOSPHOLIP SYNDROME - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:25

Manufacturer products 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

Manufacturer products View details