Identity
- Trade Name
- ORTHOTM Sera Anti-Fyb FDA UDI
- Generic Name
- Anti-Fy^b red blood cell grouping IVD, antibody FDA UDI
- Device Name
- The Anti-Fyb reagent (Anti-FY2) is for the qualitative in vitro detection of human Fyb positive red blood cells by the indirect antiglobulin test. FDA UDI
- Model / Reference
- 6904547 FDA UDI
- Description
- The Anti-Fyb reagent (Anti-FY2) is for the qualitative in vitro detection of human Fyb positive red blood cells by the indirect antiglobulin test. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10758750013012 FDA UDI
- GMDN Term
- Anti-Fy^b 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
No
FDA UDI
Prescription Use
Yes
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
Category: Anti-Fy^b red blood cell grouping IVD, antibody
ORTHOTM Sera Anti-Fyb by Alba Bioscience Limited — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anti-Fy^b red blood cell grouping IVD, antibody.
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
- Alba Bioscience Limited
Sources (1)
- FDA UDI 0d8e844c-4222-4b6d-83a6-c8acb3b7c2ef 35 fields · synced May 31, 2026