← Back to catalogue
Cytokeratin (CAM 5.2) Mouse Monoclonal Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 452M-94Model 452M-9X seriesRef 452M-97
Identity
- Trade Name
- Cytokeratin (CAM 5.2) Mouse Monoclonal Antibody EUDAMEDFDA UDI
- Generic Name
- Cytokeratin IVD, antibody FDA UDI
- Device Name
- Cytokeratin (CAM 5.2) Mouse Monoclonal Antibody EUDAMED
- Model / Reference
- 452M-94 EUDAMEDFDA UDI452M-97 EUDAMEDFDA UDI452M-9X series EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841683142652 EUDAMEDFDA UDI00841683142683 EUDAMEDFDA UDI
- Basic UDI-DI
- 008416831452M-9DJ EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Cytokeratin IVD, antibody FDA UDI
Classification
- Device Class
- Class C 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
No
FDA UDI
Category: Cytokeratin IVD, antibody
Cytokeratin (CAM 5.2) Mouse Monoclonal Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Cytokeratin IVD, antibody.
- ANTI-CYTOKERATIN PAN — Biogenex Laboratories, Inc. · Class I
- Rabbit Monoclonal Anti-Human Cytokeratin 13 Antibody, EP69 — EPITOMICS, INC. · Class I
- Mouse Monoclonal Anti-Human CK-HMW(MX134) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- Cytokeratin 17 RMab — BIO SB, INC. · Class I
- Tinto Cytokeratin 7 & CDX2, RMab — BIO SB, INC. · Class I
- Cytokeratin 13 RMab — BIO SB, INC. · Class I
- Novocastra™ — Leica Biosystems Newcastle, Limited · Class I
- Rabbit Monoclonal Anti-Human Cytokeratin 19 Antibody, EP72 — EPITOMICS, INC. · 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 (4)
- FDA UDI 37060435-7879-47f8-a260-7af6a3d865c0 33 fields · synced Jul 17, 2026
- FDA UDI 6853f7ba-b979-4543-ac66-2c549d18d278 33 fields · synced May 30, 2026
- EUDAMED cd81eaba-5dae-4d65-b7a5-d10ef3857e4b 61 fields · synced Jul 16, 2026
- EUDAMED 93fc4fde-85b2-44a6-aaa7-49fb1e2b92ec 61 fields · synced Jul 17, 2026