Fluorion
by Iontek Ilac Tani Ve Biyoteknoloji Urunleri Ar. Ge. San. Tic. A.S. Türkiye EUDAMED
Ref M0380202, M0010202, M0060202, M1360102, M1490102-5, M1380102, M1390102, M0630102, M0360202
EMDN W0105040205
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-08698898740799 | Date10 Jun 2022 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Device Name
- Fluorion CMV QNP 3.0 Real-Time PCR KitFluorion HBV QNP 2.0 Real-Time PCR KitFluorion HDV QNP 1.0 Real-Time PCR KitFluorion Covidenza QLP 1.0 Real-Time PCR KitFluorion nCoV-19 QLP 2.2 Real-Time PCR KitFluorion Covidenza Plus QLP 2.0 Real-Time PCR KitFluorion Covidenza Plus QLP 3.0 Real-Time PCR KitFluorion VRE QLP 1.0 Real-Time PCR KitFluorion EBV QNP 1.0 EBV Real-Time PCR Kit
- Model / Reference
- M0380202, M0010202, M0060202, M1360102, M1490102-5, M1380102, M1390102, M0630102, M0360202
- Primary DI / UDI-DI
- 08698898740799, 08698898740010, 08698898740621, 08698898741000, 08698898741796, 08698898741048, 08698898741055, 08698898740539, 08698898740133
- Basic UDI-DI
- B-08698898740799, B-08698898740010, B-08698898740621, B-08698898741000, B-08698898741796, B-08698898741048, B-08698898741055, B-08698898740539, B-08698898740133
- EMDN Code
- W0105040205, W0105020216, W0105020406, W0105070302, W0105040519, W0104080604, W0105040403
- Device Class
- Class IVD Annex II List BClass IVD Annex II List AClass IVD General
- Market of Registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000023054
Other devices from Iontek Ilac Tani Ve Biyoteknoloji Urunleri Ar. Ge. San. Tic. A.S.
See all devices from Iontek Ilac Tani Ve Biyoteknoloji Urunleri Ar. Ge. San. Tic. A.S. →
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (9)
- EUDAMED 1adaffe4-cc6e-4784-99ce-964fa46a7dfb
- EUDAMED 08698898740010|B-08698898740010
- EUDAMED 08698898740621|B-08698898740621
- EUDAMED 08698898741000|B-08698898741000
- EUDAMED 08698898741796|B-08698898741796
- EUDAMED 08698898741048|B-08698898741048
- EUDAMED 08698898741055|B-08698898741055
- EUDAMED 08698898740539|B-08698898740539
- EUDAMED 08698898740133|B-08698898740133