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FLEX Mono Mo A-Hu Cytokeratin Cl AE1/AE3 RTU (Link)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- FLEX Mono Mo A-Hu Cytokeratin Cl AE1/AE3 RTU (Link) FDA UDI
- Generic Name
- Cytokeratin IVD, antibody FDA UDI
- Device Name
- FLEX Monoclonal Mouse Anti-Human Cytokeratin Clone AE1/AE3 Ready-to-Use (Link) FDA UDI
- Model / Reference
- IR053 FDA UDI
- Description
- FLEX Monoclonal Mouse Anti-Human Cytokeratin Clone AE1/AE3 Ready-to-Use (Link) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700571101667 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
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
FLEX Mono Mo A-Hu Cytokeratin Cl AE1/AE3 RTU (Link) by Agilent Technologies Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cytokeratin IVD, antibody.
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- 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 (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
- Agilent Technologies Inc.
Sources (1)
- FDA UDI 19e0de20-780c-4384-9ad3-7d12078ee9a4 36 fields · synced May 30, 2026