← Back to catalogue
p57/Kip2 (Kp10) Mouse Monoclonal Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 760-4617
Identity
- Trade Name
- anti-p57Kip2 (Kp10) Mouse Monoclonal Primary Antibody EUDAMEDp57/Kip2 (Kp10) Mouse Monoclonal Antibody FDA UDI
- Generic Name
- P57 protein IVD, antibody FDA UDI
- Device Name
- anti-p57Kip2 (Kp10) Mouse Monoclonal Primary Antibody EUDAMED
- Model / Reference
- 760-4617 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841683101321 EUDAMEDFDA UDI
- Basic UDI-DI
- 008416831760-46172M EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- P57 protein IVD, antibody FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: P57 protein IVD, antibody
p57/Kip2 (Kp10) Mouse Monoclonal Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as P57 protein IVD, antibody.
- Rabbit Monoclonal Anti-Human p57/Kip2 Antibody, EP183 — EPITOMICS, INC. · Class I
- Rabbit Monoclonal Anti-Human p57/Kip2 Antibody, EP183 — EPITOMICS, INC. · Class I
- Novocastra — Leica Biosystems Newcastle, Limited · Class I
- Rabbit Monoclonal Anti-Human p57/Kip2 Antibody, EP183 — EPITOMICS, INC. · Class I
- Rabbit Monoclonal Anti-Human p57/Kip2 Antibody, EP183 — EPITOMICS, INC. · Class I
- p57/Kip2 (Kp10) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- p57/Kip2 (Kp10) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- p57/Kip2 (Kp10) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cell Marque Corporation
Sources (2)
- FDA UDI 1646977f-9a09-4273-bd53-5befa4bc26b1 33 fields · synced Jul 16, 2026
- EUDAMED 69cb4ac7-2f49-4ea2-afd4-33affd9f1dfa 61 fields · synced Jul 16, 2026