Home › Device types › GMD
Antisera, Latex Agglutination, Cryptococcus Neoformans
FDA product code GMD · Class 2 · Microbiology
11
Registered devices
2
Adverse events
3
Recalls
10
510(k) clearances
Devices with this code
IMMY — Immuno-Mycologics, Inc.Cryptococcal Antigen Latex Agglutination System (CALAS) — MERIDIAN BIOSCIENCE, INC.NA — REMEL, INC.NA — OXOID LIMITEDIMMY — Immuno-Mycologics, Inc.IMMY — Immuno-Mycologics, Inc.IMMY — Immuno-Mycologics, Inc.NA — REMEL, INC.IMMY — Immuno-Mycologics, Inc.IMMY — Immuno-Mycologics, Inc.CALAS Pronase — MERIDIAN BIOSCIENCE, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-01-03 | Immuno-Mycologics, Inc | The firm found immunoassay products used to detect cryptococcal antigen in serum and cerebrospinal fluid to have reduced specificity (90% now versus 99% before) |
| 2018-03-30 | Immuno-Mycologics, Inc | Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results |
| 2016-12-27 | Immuno-Mycologics, Inc | The affected products have approximately a 91% specificity while the non-affected lots have approximately a 99% specificity. The recalling firm is aware of thre |
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