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Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay]
BIOMERICA, INC. · Model 7069 · UDI-DI 08305900070699
10
510(k) clearances
2
Adverse events
6
Recalls
17
Facilities
Description
The Biomerica Giardia ELISA is intended for the qualitative detection of Giardia antigen in fecal specimens. This assay is intended for research use only.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-03-24 | MEDLINE INDUSTRIES, LP - Northfield | A single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit was inadvertently stored in Medline warehouses at temperatures outside of the labeled storage requirements. |
| 2008-08-11 | Remel, Inc | Faint grey test lines for Cryptosporidium may be visible which may be interpreted as false positive |
| 2004-02-23 | Genzyme Diagnostics | False Positive results. |
| 2003-12-09 | Remel, Inc. | The conjugate may cause the negative control to produce high OD readings, therefore invalidating the run. |
| 2002-11-21 | Remel, Inc. | The conjugate of the ProSpecT Giardia/Cryptosporidium Microplate Assay, Lot #926230, may have become contaminated during filling. The particulates in the contamination may cause t |
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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.