Identity
- Trade Name
- Anti-Fya (FY1) FDA UDI
- Generic Name
- Anti-Fy^a red blood cell grouping IVD, antibody FDA UDI
- Device Name
- Blood Grouping Reagent, Anti-Fya (Human/Murine Monoclonal) (IgG) (DG-FYA-02) - These reagents are designed to determine the presence of the blood group antigen Fya on the surface of human red blood cells by manual tube method. FDA UDI
- Model / Reference
- 210531 FDA UDI
- Description
- Blood Grouping Reagent, Anti-Fya (Human/Murine Monoclonal) (IgG) (DG-FYA-02) - These reagents are designed to determine the presence of the blood group antigen Fya on the surface of human red blood cells by manual tube method. FDA UDI
Identifiers
- Catalog Number
- 210531 FDA UDI
- Primary DI / UDI-DI
- 23661562105315 FDA UDI
- GMDN Term
- Anti-Fy^a red blood cell grouping IVD, antibody FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Anti-Fy^a red blood cell grouping IVD, antibody
Anti-Fya (FY1) by Diagast — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anti-Fy^a red blood cell grouping IVD, antibody.
- ALBAclone Anti-Fya (Monoclonal IgG) — ALBA BIOSCIENCE LIMITED
- Gamma-Clone Anti-Fya (Monoclonal) Blood Grouping Reagent — IMMUCOR, INC.
- ORTHOTM Sera Anti-Fya — ALBA BIOSCIENCE LIMITED
- Seraclone® Anti-Fya (JK1) — Bio-Rad Medical Diagnostics GmbH
- Anti-Fya (Monoclonal) Gamma-clone — IMMUCOR, INC.
- Anti-Fya — IMMUCOR, INC.
- Anti-Fya — AMERICAN NATIONAL RED CROSS
- ORTHO — Ortho-Clinical Diagnostics
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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diagast
Sources (1)
- FDA UDI a3dbb114-ba74-4b42-9bb9-4ee60071d270 35 fields · synced May 30, 2026