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p16INK4A (JC2) Mouse Monoclonal Antibody
EUDAMEDClass C (EU MDR)
Ref 416M-14Model 416M-1X series
Identity
- Trade Name
- p16INK4A (JC2) Mouse Monoclonal Antibody EUDAMED
- Device Name
- p16INK4A (JC2) Mouse Monoclonal Antibody EUDAMED
- Model / Reference
- 416M-1X series EUDAMED416M-14 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841683114581 EUDAMED
- Basic UDI-DI
- 008416831416M-1CJ EUDAMED
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
p16INK4A (JC2) Mouse Monoclonal Antibody by Cell Marque Corporation — Class C — 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 | 008416831416M-1CJ | Class C | Active |
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Manufacturer
- Manufacturer
- Cell Marque Corporation
- EUDAMED SRN
- US-MF-000028332
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 7864d11a-ca4f-438b-b7c3-ac26cfb17191 61 fields · synced May 22, 2026