Identity
- Trade Name
- Anti Pan Cytokeratin Antibody FDA UDI
- Generic Name
- Cytokeratin IVD, antibody FDA UDI
- Device Name
- Anti Pan Cytokeratin Antibody is a mouse monoclonal antibody to cytokeratin epitopes [C-11] conjugated with Phycoerythrin (PE). FDA UDI
- Model / Reference
- U31100 FDA UDI
- Description
- Anti Pan Cytokeratin Antibody is a mouse monoclonal antibody to cytokeratin epitopes [C-11] conjugated with Phycoerythrin (PE). FDA UDI
Identifiers
- Catalog Number
- U31100 FDA UDI
- Primary DI / UDI-DI
- B766U311000 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Cytokeratin IVD, antibody FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 100 Microliter FDA UDI
Category: Cytokeratin IVD, antibody
Anti Pan Cytokeratin Antibody by Incelldx, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Rabbit Monoclonal Anti-Human Cytokeratin 19 Antibody, EP72 — EPITOMICS, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Incelldx, Inc
Sources (1)
- FDA UDI 63501d23-086d-44b4-9e54-73125f80ead7 36 fields · synced Jun 9, 2026