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p16INK4A (JC2) Mouse Monoclonal Antibody
EUDAMEDClass C (EU MDR)
Ref 416M-17Model 416M-1X seriesRef 416M-10Ref 416M-15Ref 416M-18
Identity
- Trade Name
- p16INK4A (JC2) Mouse Monoclonal Antibody EUDAMED
- Device Name
- p16INK4A (JC2) Mouse Monoclonal Antibody EUDAMED
- Model / Reference
- 416M-1X series EUDAMED416M-17 EUDAMED416M-10 EUDAMED416M-15 EUDAMED416M-18 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841683114437 EUDAMED00841683118640 EUDAMED00841683117988 EUDAMED00841683117971 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 (4)
- EUDAMED 6646522e-25b6-48c5-aa8d-f666072aba52 61 fields · synced Jul 31, 2026
- EUDAMED c1e353e7-2fe6-4321-9ea0-3bcf70a16e70 61 fields · synced May 17, 2026
- EUDAMED 427dbb41-7e1e-4953-acc4-b156f3e2cbad 61 fields · synced May 18, 2026
- EUDAMED 06270cf2-fb3c-4c02-81f1-926757512a9c 61 fields · synced May 18, 2026