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RTA MB VIRAL NUCLEIC ACID ISOLATION KIT (48 Tests)
EUDAMEDClass A (EU MDR)
Ref 09015048Model 12 Tests/ Kit, 24 Tests/ Kit, 48 Tests/ Kit
by RTA Laboratuvarları Biyolojik Ürünler İlaç ve Makine Sanayi Ticaret Anonim Şirketi
Identity
- Trade Name
- RTA MB VIRAL NUCLEIC ACID ISOLATION KIT (48 Tests) EUDAMED
- Device Name
- Nucleic Acid Isolation Kit (Magnetic Bead Method) EUDAMED
- Model / Reference
- 12 Tests/ Kit, 24 Tests/ Kit, 48 Tests/ Kit EUDAMED09015048 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698918034822 EUDAMED
- Basic UDI-DI
- 86989180309015AG EUDAMED
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
New Device
No
EUDAMED
Category: Nucleic acid extraction/isolation kit IVD
RTA MB VIRAL NUCLEIC ACID ISOLATION KIT (48 Tests) by RTA Laboratuvarları Biyolojik Ürünler İlaç ve Makine Sanayi Ticaret Anonim Şirketi — Class A — IVDR…
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Also classified as Nucleic acid extraction/isolation kit IVD.
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- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 86989180309015AG | Class A | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000021258
Sources (1)
- EUDAMED 67edeab2-dd76-4764-a3f4-64d64c08ef31 61 fields · synced Jul 10, 2026