← Back to catalogue
FLEX Mono Mo A-Hu B-Cell-Specific Activator Protein Cl DAK-Pax5 RTU (Link)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- FLEX Mono Mo A-Hu B-Cell-Specific Activator Protein Cl DAK-Pax5 RTU (Link) FDA UDI
- Generic Name
- B-cell specific activator protein (BSAP) IVD, antibody FDA UDI
- Device Name
- FLEX Monoclonal Mouse Anti-Human B-Cell-Specific Activator Protein Clone DAK-Pax5 Ready-to-Use (Link) FDA UDI
- Model / Reference
- IR650 FDA UDI
- Description
- FLEX Monoclonal Mouse Anti-Human B-Cell-Specific Activator Protein Clone DAK-Pax5 Ready-to-Use (Link) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700572030843 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- B-cell specific activator protein (BSAP) 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: B-cell specific activator protein (BSAP) IVD, antibody
FLEX Mono Mo A-Hu B-Cell-Specific Activator Protein Cl DAK-Pax5 RTU (Link) by Agilent Technologies Singapore Pte Ltd — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as B-cell specific activator protein (BSAP) IVD, antibody.
- PAX-5 (24) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- PAX-5 (SP34) Rabbit Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- ANTI-PAX-5 — Biogenex Laboratories, Inc. · Class I
- PAX-5 (SP34) Rabbit Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- PAX5 — BIOCARE MEDICAL, LLC · Class I
- PAX-5 (24) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- PAX-5 (EP156) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
- CONFIRM anti-PAX5 (SP34) Rabbit Monoclonal Primary Antibody — Ventana Medical Systems · 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 ff87afc4-a8a1-414c-b6f6-804b61ac8544 36 fields · synced May 30, 2026