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VIDAS® HCG

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064914
Basic UDI-DI: 357302BUDI000894UM
Reference: 30405
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:57

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VIDAS® Testosterone II

IVD Class BIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026415686
Basic UDI-DI: 357302BUDI000162T5
Reference: 414320
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:51

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VIDAS® Prolactin

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064969
Basic UDI-DI: 357302BUDI000009SU
Reference: 30410
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:48

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VIDAS® Progesterone

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064952
Basic UDI-DI: 357302BUDI000008SS
Reference: 30409
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:48

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VIDAS® FSH

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064938
Basic UDI-DI: 357302BUDI000007SQ
Reference: 30407
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:48

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VIDAS® LH

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064921
Basic UDI-DI: 357302BUDI000609TS
Reference: 30406
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:48

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RIA Unconjugated Estriol

Immunoassay IM3594

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590219765
Basic UDI-DI: 150995905IM35946Q
Reference: IM3594
EMDN: W0102050203
EMDN description: UNCONJUGATED (FREE) ESTRIOL
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:45

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SHBG IRMA KIT

Immunoassay IM3532

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590219635
Basic UDI-DI: 150995905IM353262
Reference: IM3532
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:45

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Free β-hCG IRMA KIT

IM2459

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590217525
Basic UDI-DI: 150995905IM24596A
Reference: IM2459
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:44

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hCG screening RIA KIT

Immunoassay IM2235

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590217044
Basic UDI-DI: 150995905IM22355J
Reference: IM2235
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:44

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FSH IRMA KIT

Immunoassay IM2125, IM3301

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590216764
Basic UDI-DI: 150995905FSHIRMATA
Reference: IM2125
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:44

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hCG IRMA KIT

IM2110

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590216689
Basic UDI-DI: 150995905hCGIRMA3X
Reference: Im2110
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:44

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RIA 17α-Hydroxyprogesterone

Immunoassay, IM1452

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590214715
Basic UDI-DI: 150995905IM14525M
Reference: IM1452
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:43

Manufacturer products View details

LH IRMA KIT

Immunoassay IM1381, IM3302

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590214401
Basic UDI-DI: 150995905LHIRMAHQ
Reference: IM1381
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:43

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RIA Progesterone

Immunoassay IM1188

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590213817
Basic UDI-DI: 150995905IM11885T
Reference: IM1188
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:43

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RIA DHEA

Immunoassay IM1138

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590213701
Basic UDI-DI: 150995905IM11385C
Reference: IM1138
EMDN: W0102050102
EMDN description: DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:43

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RIA Testosterone, direct

Immunoassay IM1119

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590213657
Basic UDI-DI: 150995905IM111958
Reference: IM1119
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:43

Manufacturer products View details

RIA Testosterone

Immunoassay IM1087

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590213626
Basic UDI-DI: 150995905IM10875L
Reference: IM1087
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:43

Manufacturer products View details

RIA Δ4-Androstenedione

Immunoassay, IM0674

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590213015
Basic UDI-DI: 150995905IM067462
Reference: IM0674
EMDN: W0102050101
EMDN description: ANDROSTENEDIONE
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:43

Manufacturer products View details

ACTIVE® Dihydrotestosterone RIA

Immunoassay DSL9600I

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590211653
Basic UDI-DI: 150995905DSL9600iRA
Reference: DSL9600i
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:43

Manufacturer products View details