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Gamma EGA Kit
IMMUCOR, INC. · Model 0007865 · UDI-DI 10888234000877
KSG
Prescription
10
510(k) clearances
11
Adverse events
1
Recalls
14
Facilities
Description
Gamma EGA Kit is intended for use in dissociation of IgG from red blood cells so that the treated red blood cells can be further antigen typed or used for serological testing.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-10-14 | Ortho Clinical Diagnostics Inc | Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when stored in a 2mL cup for 7 |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.
