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25 device results listed.

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Human PIK3CA Gene Mutation Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSterile

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733169
Basic UDI-DI: B-06955792733169
Reference: S3063E
EMDN: W0106010114
EMDN description: PROTHROMBIN MUTATION
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:59

Manufacturer products Authorised representative products Authorised representative actors View details

Human KRAS Gene 7 Mutations Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733152
Basic UDI-DI: B-06955792733152
Reference: S3058E
EMDN: W0106010114
EMDN description: PROTHROMBIN MUTATION
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:59

Manufacturer products Authorised representative products Authorised representative actors View details

Human EGFR Gene 29 Mutations Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733145
Basic UDI-DI: B-06955792733145
Reference: S3059E
EMDN: W0106010114
EMDN description: PROTHROMBIN MUTATION
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:59

Manufacturer products Authorised representative products Authorised representative actors View details

Human BRAF Gene V600E Mutation Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733138
Basic UDI-DI: B-06955792733138
Reference: S3064E
EMDN: W0106010114
EMDN description: PROTHROMBIN MUTATION
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:59

Manufacturer products Authorised representative products Authorised representative actors View details

LAMP Human Prothrombin mutation KIT (rs1799963)

LC-FII-LP-96

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430002471013
Basic UDI-DI: B-05430002471013
Reference: LC-FII-LP-96
EMDN: W0106010114
EMDN description: PROTHROMBIN MUTATION
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:49

Manufacturer products View details

LAMP Human Prothrombin mutation KIT (rs1799963)

LC-FII-LP

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430002471006
Basic UDI-DI: B-05430002471006
Reference: LC-FII-LP-24
EMDN: W0106010114
EMDN description: PROTHROMBIN MUTATION
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:49

Manufacturer products View details

05061059980199

ZENA MAX Human Factor II Prothrombin “20210 Mutation” Real Time PCR Kit

IVD generalIVDDOn the marketKitReagent

Manufacturer: Advanced Molecular Diagnostics Ltd
Manufacturer SRN: UK-MF-000043044
UDI-DI: 05061059980199
Basic UDI-DI: B-05061059980199
Reference: KD184567-100
EMDN: W0106010114
EMDN description: PROTHROMBIN MUTATION
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 02.08.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

08033629922165

FATTORE II (G20210) Real time (FRET)

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Nuclear Laser Medicine srl
Manufacturer SRN: IT-MF-000025709
UDI-DI: 08033629922165
Basic UDI-DI: 803362992GENPREDQ3
Reference: AA831/50A
EMDN: W0106010114
EMDN description: PROTHROMBIN MUTATION
First on market country: Italy
Authorised representative: -
Last updated: 23.07.2026 23:02

Manufacturer products View details

08033629923964

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Nuclear Laser Medicine srl
Manufacturer SRN: IT-MF-000025709
UDI-DI: 08033629923964
Basic UDI-DI: 803362992GENPREDQ3
Reference: FA097/10
EMDN: W0106010114
EMDN description: PROTHROMBIN MUTATION
First on market country: -
Authorised representative: -
Last updated: 23.07.2026 22:38

Manufacturer products View details

geneMAP

geneMAP FII Mutation Detection Kit, 50T

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000028405
UDI-DI: D-TRMF000028405FIIRT50H2
Basic UDI-DI: B-TRMF000028405FIIRT50H2
Reference: FII-RT50
EMDN: W0106010114
EMDN description: PROTHROMBIN MUTATION
First on market country: Türkiye
Authorised representative: -
Last updated: 15.07.2026 11:22

Manufacturer products View details

Thrombosis-Q Comprehensive Real Time PCR Kit

G2M803421

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2M803421FH
Basic UDI-DI: B-G2M803421FH
Reference: G2M803421, G2M803421R
EMDN: W0106010114
EMDN description: PROTHROMBIN MUTATION
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:45

Manufacturer products Authorised representative products Authorised representative actors View details

TaqPath™ Menu | GeneProof™ Factor II Prothrombin PCR Kit

GeneProof Factor II Prothrombin PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696304270
Basic UDI-DI: B-08595696304270
Reference: A58420
EMDN: W0106010114
EMDN description: PROTHROMBIN MUTATION
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:59

Manufacturer products View details

GeneProof Factor II Prothrombin MC PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696302719
Basic UDI-DI: B-08595696302719
Reference: FII/MC/040
EMDN: W0106010114
EMDN description: PROTHROMBIN MUTATION
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:58

Manufacturer products View details

GeneProof Factor II Prothrombin MC PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08594161958505
Basic UDI-DI: B-08594161958505
Reference: FII/MC/200
EMDN: W0106010114
EMDN description: PROTHROMBIN MUTATION
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:49

Manufacturer products View details

GeneProof Factor II Prothrombin PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08594161956969
Basic UDI-DI: B-08594161956969
Reference: FII/025
EMDN: W0106010114
EMDN description: PROTHROMBIN MUTATION
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:48

Manufacturer products View details

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

Manufacturer products View details

08057723370073

SMART SNP FII Direct Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOCLARMA S.R.L.
Manufacturer SRN: IT-MF-000030384
UDI-DI: 08057723370073
Basic UDI-DI: B-08057723370073
Reference: SNPD-029
EMDN: W0106010114
EMDN description: PROTHROMBIN MUTATION
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:35

Manufacturer products View details

MutaREAL® Faktor II

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598003118
Basic UDI-DI: B-04050598003118
Reference: KF291696
EMDN: W0106010114
EMDN description: PROTHROMBIN MUTATION
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:42

Manufacturer products View details

MutaREAL® Faktor II

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598002913
Basic UDI-DI: B-04050598002913
Reference: KF291632
EMDN: W0106010114
EMDN description: PROTHROMBIN MUTATION
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:42

Manufacturer products View details

MutaPLATE® Faktor II (TM)

MutaPLATE® Factor II (TM)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598002647
Basic UDI-DI: B-04050598002647
Reference: KF1901632
EMDN: W0106010114
EMDN description: PROTHROMBIN MUTATION
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:41

Manufacturer products View details