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796 device results listed.

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GeneProof PAI1 Genotyping PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08594161955399
Basic UDI-DI: B-08594161955399
Reference: PAI1/100
EMDN: W0106010116
EMDN description: OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:48

Manufacturer products View details

GeneProof MTHFR C677T PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08594161955320
Basic UDI-DI: B-08594161955320
Reference: M677/100
EMDN: W0106010116
EMDN description: OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:48

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GeneProof MTHFR A1298C PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08594161955221
Basic UDI-DI: B-08594161955221
Reference: M1298/100
EMDN: W0106010116
EMDN description: OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:48

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GeneProof Factor II Prothrombin PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08594161955122
Basic UDI-DI: B-08594161955122
Reference: FII/100
EMDN: W0106010114
EMDN description: PROTHROMBIN MUTATION
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:48

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GeneProof Factor V Leiden PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08594161955023
Basic UDI-DI: B-08594161955023
Reference: FV/100
EMDN: W0106010103
EMDN description: FACTOR V LEIDEN
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:48

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Genvinset® deltaF508 96 tests

Genvinset® deltaF508

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942901
Basic UDI-DI: B-08437016942901
Reference: GVS-DF508-96
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:55

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Genvinset® deltaF508 48 tests

Genvinset® deltaF508

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSterile

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942895
Basic UDI-DI: B-08437016942895
Reference: GVS-DF508-48
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:55

Manufacturer products View details

Genvinset® deltaF508 24 tests

Genvinset® deltaF508

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942888
Basic UDI-DI: B-08437016942888
Reference: GVS-DF508-24
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:55

Manufacturer products View details

Genvinset® HFE C282Y 96 tests

Genvinset® HFE C282Y

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942741
Basic UDI-DI: B-08437016942741
Reference: GVS-C282Y-96
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:55

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Genvinset® HFE H63D 96 tests

Genvinset® HFE H63D

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942734
Basic UDI-DI: B-08437016942734
Reference: GVS-H63D-96
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:55

Manufacturer products View details

Genvinset® MTHFR A1298C 96 tests

Genvinset® MTHFR A1298C

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942727
Basic UDI-DI: B-08437016942727
Reference: GVS-A1298C-96
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:55

Manufacturer products View details

Genvinset® MTHFR C677T 96 tests

Genvinset® MTHFR C677T

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942710
Basic UDI-DI: B-08437016942710
Reference: GVS-MTHFR-96
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:55

Manufacturer products View details

Genvinset® Factor V G1691A 96 tests

Genvinset® Factor V G1691A

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942703
Basic UDI-DI: B-08437016942703
Reference: GVS-FV-96
EMDN: W0106010103
EMDN description: FACTOR V LEIDEN
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:55

Manufacturer products View details

Genvinset® HLA B57v5 48 tests

Genvinset® HLA B57v5

IVD Annex II List BIVDDOn the marketCompanion diagnosticsKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942680
Basic UDI-DI: B-08437016942680
Reference: GVS-B5705-48
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:55

Manufacturer products View details

Genvinset® HLA B57v5 24 tests

Genvinset® HLA B57v5

IVD Annex II List BIVDDOn the marketCompanion diagnosticsKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942673
Basic UDI-DI: B-08437016942673
Reference: GVS-B5705-24
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:55

Manufacturer products View details

Genvinset® MTHFR A1298C 48 tests

Genvinset® MTHFR A1298C

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942574
Basic UDI-DI: B-08437016942574
Reference: GVS-A1298C-48
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:55

Manufacturer products View details

Genvinset® MTHFR A1298C 24 tests

Genvinset® MTHFR A1298C

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942567
Basic UDI-DI: B-08437016942567
Reference: GVS-A1298C-24
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:53

Manufacturer products View details

Genvinset® MTHFR C677T 48 tests

Genvinset® MTHFR C677T

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942406
Basic UDI-DI: B-08437016942406
Reference: GVS-MTHFR-48
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:53

Manufacturer products View details

Genvinset® MTHFR C677T 24 tests

Genvinset® MTHFR C677T

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942390
Basic UDI-DI: B-08437016942390
Reference: GVS-MTHFR-24
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:53

Manufacturer products View details

Genvinset® Factor V G1691A 48 tests

Genvinset® Factor V G1691A

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942383
Basic UDI-DI: B-08437016942383
Reference: GVS-FV-48
EMDN: W0106010103
EMDN description: FACTOR V LEIDEN
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:53

Manufacturer products View details