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SARS-CoV-2 RT-qPCR DETECTION KIT
EUDAMEDClass IVD General (EU MDR)
Ref KSC2-AB69
Identity
- Trade Name
- SARS-CoV-2 RT-qPCR DETECTION KIT EUDAMED
- Device Name
- SARS-CoV-2 RT-qPCR DETECTION KIT EUDAMED
- Model / Reference
- KSC2-AB69 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-KSC2-AB692F EUDAMED
- Basic UDI-DI
- B-KSC2-AB692F EUDAMED
- EMDN Code
- W0105041106 CORONAVIRUS - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
SARS-CoV-2 RT-qPCR DETECTION KIT by Appolon Bioteck — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-KSC2-AB692F | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Appolon Bioteck
- EUDAMED SRN
- FR-MF-000022234
Sources (1)
- EUDAMED b14e9c74-aa58-4a55-86c7-fc1b346e3545 61 fields · synced Jun 19, 2026