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FLEX Mono Mo A-Hu CD31, Endothelial Cell Cl JC70A RTU
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- FLEX Mono Mo A-Hu CD31, Endothelial Cell Cl JC70A RTU FDA UDI
- Generic Name
- CD31 endothelial cell marker IVD, antibody FDA UDI
- Device Name
- FLEX Monoclonal Mouse Anti-Human CD31, Endothelial Cell Clone JC70A Ready-to-Use (Dako Autostainer/ Autostainer Plus) FDA UDI
- Model / Reference
- IS610 FDA UDI
- Description
- FLEX Monoclonal Mouse Anti-Human CD31, Endothelial Cell Clone JC70A Ready-to-Use (Dako Autostainer/ Autostainer Plus) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700572028987 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- CD31 endothelial cell marker 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: CD31 endothelial cell marker IVD, antibody
FLEX Mono Mo A-Hu CD31, Endothelial Cell Cl JC70A RTU by Agilent Technologies Singapore Pte Ltd — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as CD31 endothelial cell marker IVD, antibody.
- Mouse Monoclonal Anti-Human CD31(MX032) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- Mouse Monoclonal Anti-Human CD31(MX032) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- CD31 (PECAM-1) — BIOCARE MEDICAL, LLC · Class I
- BOND — Leica Biosystems Newcastle, Limited · Class I
- IHC — Slmp, LLC · Class I
- Mouse Monoclonal Anti-Human CD31(MX032) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
- BOND™ — Leica Biosystems Newcastle, Limited · 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 Singapore Pte Ltd
Sources (1)
- FDA UDI 57a2de9a-0019-449d-9206-49ab9d2b5c55 36 fields · synced Jun 8, 2026