Identity
- Trade Name
- Poly Rb A-Hu Albumin/FITC FDA UDI
- Generic Name
- Albumin IVD, antibody FDA UDI
- Device Name
- Polyclonal Rabbit Anti-Human Albumin/FITC FDA UDI
- Model / Reference
- F0117 FDA UDI
- Description
- Polyclonal Rabbit Anti-Human Albumin/FITC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700572002390 FDA UDI
- FDA Product Code
- DDZ FDA UDI
- GMDN Term
- Albumin IVD, antibody FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5040 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 2 Milliliter FDA UDI
Category: Albumin IVD, antibody
Poly Rb A-Hu Albumin/FITC by Agilent Technologies Singapore Pte Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Albumin IVD, antibody.
- IHC — Slmp, LLC · Class I
- Human Albumin NL BINDARID™ Radial Immunodiffusion Kit — The Binding Site Group · Class II
- FITC Anti-Albumin Primary Antibody — Ventana Medical Systems · Class I
- Antiserum to Human Albumin — KENT LABORATORIES, INC. · Class II
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 II | 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 bf6ea584-aa95-491c-b205-923690ac3241 36 fields · synced May 31, 2026