Identity
- Trade Name
- BOND FDA UDI
- Generic Name
- Cytokeratin IVD, antibody FDA UDI
- Device Name
- Cytokeratin 7 (RN7) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratin 7 intermediate filament protein 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
- PA0942-U FDA UDI
- Description
- Cytokeratin 7 (RN7) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratin 7 intermediate filament protein 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
- PA0942-U FDA UDI
- Primary DI / UDI-DI
- 05055331335524 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
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
- Rabbit Monoclonal Anti-Human Cytokeratin 19 Antibody, EP72 — EPITOMICS, INC. · Class I
- Rabbit Monoclonal Anti-Human Cytokeratin 5 Antibody, EP42 — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Leica Biosystems Newcastle, Limited
Sources (1)
- FDA UDI 66bccd43-43fd-4504-9a35-ebef678f10cc 36 fields · synced May 31, 2026