Identity
- Trade Name
- FLEX Mono Mo A-Hu CD8 Cl C8/144B RTU FDA UDI
- Generic Name
- CD8 cell marker IVD, antibody FDA UDI
- Device Name
- FLEX Monoclonal Mouse Anti-Human CD8 Clone C8/144B Ready-to-Use (Dako Autostainer/ Autostainer Plus) FDA UDI
- Model / Reference
- IS623 FDA UDI
- Description
- FLEX Monoclonal Mouse Anti-Human CD8 Clone C8/144B Ready-to-Use (Dako Autostainer/ Autostainer Plus) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700572029823 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- CD8 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: CD8 cell marker IVD, antibody
FLEX Mono Mo A-Hu CD8 Cl C8/144B RTU by Agilent Technologies Singapore Pte Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as CD8 cell marker IVD, antibody.
- CD8 [C8/144B] — BIOCARE MEDICAL, LLC · Class I
- Mouse Monoclonal Anti-Human CD8(MX117) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- CD8 (SP16) Rabbit Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- CD8 — BIOCARE MEDICAL, LLC · Class I
- Human CD8 PE-Alexa Fluor® 610 Conj. — LIFE TECHNOLOGIES LIMITED · Class I
- Mouse Monoclonal Anti-Human CD8(MX117) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- Human CD8 Alexa Fluor® 700 Conjugate — LIFE TECHNOLOGIES LIMITED · Class I
- Tissue-Tek Genie® — Sakura Finetek USA, 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
- Agilent Technologies Singapore Pte Ltd
Sources (1)
- FDA UDI 213d9cb7-7bc4-4811-8c4d-f69874f5793e 36 fields · synced Jun 8, 2026