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TB Fluorescent Stain Kit II (Auramine Rhodamine Phenol)
EUDAMEDClass A (EU MDR)
Ref RRSK19-100Model Stain Kit
Identity
- Trade Name
- TB Fluorescent Stain Kit II (Auramine Rhodamine Phenol) EUDAMED
- Model / Reference
- Stain Kit EUDAMEDRRSK19-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055914762402 EUDAMED
- Basic UDI-DI
- 505591470RRSKG4 EUDAMED
- EMDN Code
- W01030708 STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Northern Ireland 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
TB Fluorescent Stain Kit II (Auramine Rhodamine Phenol) by Atom Scientific Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 505591470RRSKG4 | Class A | Active |
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Manufacturer
- Manufacturer
- Atom Scientific Ltd
- EUDAMED SRN
- UK-MF-000046578
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED bb553670-6f68-4a44-b095-8a9e99c10396 61 fields · synced Jul 17, 2026