← Back to catalogue
Acid Fast Bacteria (AFB) Stain Kit 500 mL ea.
EUDAMEDClass A (EU MDR)
Ref FAB-500
Identity
- Trade Name
- Acid Fast Bacteria (AFB) Stain Kit 500 mL ea. EUDAMED
- Device Name
- Stain Solutions EUDAMED
- Model / Reference
- FAB-500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810108715580 EUDAMED
- Basic UDI-DI
- 081010871W01030708FG EUDAMED
- Direct Marketing DI
- 00810108715580 EUDAMED
- EMDN Code
- W01030708 STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
Acid Fast Bacteria (AFB) Stain Kit 500 mL ea. by ScyTek Laboratories Inc. — 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 | 081010871W01030708FG | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ScyTek Laboratories Inc.
- EUDAMED SRN
- US-MF-000023816
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED afcf64d2-fd9f-400e-8f27-cf7c47e5a962 61 fields · synced Jul 13, 2026