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Gamma-Clone Anti-Fya (Monoclonal) Blood Grouping Reagent
FDA UDIIdentity
- Trade Name
- Gamma-Clone Anti-Fya (Monoclonal) Blood Grouping Reagent FDA UDI
- Generic Name
- Anti-Fy^a red blood cell grouping IVD, antibody FDA UDI
- Device Name
- Gamma-clone Anti-Fya (Monoclonal) Blood Grouping Reagent is intended for the detection of the Fya (FY1) antigen on red blood cells with the indirect antiglobulin test by tube and microplate technique. Gamma-clone Anti-Fya (Monoclonal) Blood Grouping Reagent is prepared from IgG antibodies from the human/murine heterohybridoma cell line P3TIM grown in fluid culture and suitably diluted in a proprietary diluent containing bovine albumin to achieve the appropriate level of potency for the test procedure as described. Sodium azide is added as a preservative (at less than 0.1% w/v). Ready for use as supplied. FDA UDI
- Model / Reference
- 10 mL size vial / 5mL fill volume FDA UDI
- Description
- Gamma-clone Anti-Fya (Monoclonal) Blood Grouping Reagent is intended for the detection of the Fya (FY1) antigen on red blood cells with the indirect antiglobulin test by tube and microplate technique. Gamma-clone Anti-Fya (Monoclonal) Blood Grouping Reagent is prepared from IgG antibodies from the human/murine heterohybridoma cell line P3TIM grown in fluid culture and suitably diluted in a proprietary diluent containing bovine albumin to achieve the appropriate level of potency for the test procedure as described. Sodium azide is added as a preservative (at less than 0.1% w/v). Ready for use as supplied. FDA UDI
Identifiers
- Catalog Number
- 0066430 FDA UDI
- Primary DI / UDI-DI
- 10888234002239 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
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^a red blood cell grouping IVD, antibody
Gamma-Clone Anti-Fya (Monoclonal) Blood Grouping Reagent by Immucor, Inc. — 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
- Anti-Fya (FY1) — DIAGAST
- ORTHOTM Sera Anti-Fya — ALBA BIOSCIENCE LIMITED
- Seraclone® Anti-Fya (JK1) — Bio-Rad Medical Diagnostics GmbH
- Anti-Fya — AMERICAN NATIONAL RED CROSS
- ORTHO — Ortho-Clinical Diagnostics
- Anti-Fya (Monoclonal) Gamma-clone — IMMUCOR, INC.
- Anti-Fya — IMMUCOR, INC.
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 |
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Manufacturer
- Manufacturer
- Immucor, Inc.
Sources (1)
- FDA UDI e299d34b-edac-4c33-b45c-ff3cc076dba4 34 fields · synced May 30, 2026