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Cytokeratin 5 (SP27) Rabbit Monoclonal Primary Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 760-4935
Identity
- Trade Name
- Cytokeratin 5 (SP27) Rabbit Monoclonal Primary Antibody EUDAMEDFDA UDI
- Generic Name
- Cytokeratin IVD, antibody FDA UDI
- Device Name
- Cytokeratin 5 (SP27) Rabbit Monoclonal Primary Antibody EUDAMED
- Model / Reference
- 760-4935 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841683101598 EUDAMEDFDA UDI
- Basic UDI-DI
- 008416831760-493536 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
Yes
FDA UDI
Category: Cytokeratin IVD, antibody
Cytokeratin 5 (SP27) Rabbit Monoclonal Primary Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Cytokeratin IVD, antibody.
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- 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 |
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Manufacturer
- Manufacturer
- Cell Marque Corporation
Sources (2)
- FDA UDI 5cabcc96-de17-4cc8-b3f7-b5066c41d343 33 fields · synced Jul 9, 2026
- EUDAMED a1aa27bc-a9d8-42cf-9962-cb6495ef239d 61 fields · synced Jul 9, 2026