Identity
- Trade Name
- BOND FDA UDI
- Generic Name
- Cytokeratin IVD, antibody FDA UDI
- Device Name
- Cytokeratin (AE1/AE3) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratins 40, 48, 50 and 56.5 kD of the acidic subfamily and 52, 56, 58, 59, 64 and 65 to 67 kD of the basic subfamily in formalin fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems). FDA UDI
- Model / Reference
- PA0094-U FDA UDI
- Description
- Cytokeratin (AE1/AE3) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratins 40, 48, 50 and 56.5 kD of the acidic subfamily and 52, 56, 58, 59, 64 and 65 to 67 kD of the basic subfamily in formalin fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems). FDA UDI
Identifiers
- Catalog Number
- PA0094-U FDA UDI
- Primary DI / UDI-DI
- 05055331334381 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Cytokeratin IVD, antibody FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1860 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cytokeratin IVD, antibody
Bond by Leica Biosystems Newcastle, Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Leica Biosystems Newcastle, Limited
Sources (1)
- FDA UDI a0a7fa82-d817-4073-85a6-0264c63cd944 36 fields · synced May 30, 2026