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TrinityBiotech
MARDX DIAGNOSTICS, INC. · Model 1206620 · UDI-DI 05391516746342
1
510(k) clearances
5
Adverse events
1
Recalls
14
Facilities
Description
Uni-Gold™ Cryptosporidium, 20 Tests
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2002-05-09 | Remel, Inc. | A potential stability problem has been identified with the Positive Controls in the referenced kit lots of the ProSpecT Cryptosporidium Microplate Assay. The Positive Control may |
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