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PREMIER Cryptococcal Antigen
MERIDIAN BIOSCIENCE, INC. · Model 602096 · UDI-DI 00840733101229
MDU
Prescription
2
510(k) clearances
0
Adverse events
1
Recalls
4
Facilities
Description
The PREMIERCryptococcal Antigen enzyme immunoassay (EIA) is a screening or a semi-quantitative test system for the detection of capsular polysaccharide antigens of Cryptococcus neoformans in serum and cerebrospinal fluid (CSF).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-12-17 | Meridian Bioscience Inc | An enzyme reagent included in the kit is not maintaining stability through claimed product expiration, resulting in the potential for false negative results when tested with patien |
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