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Immunalysis
IMMUNALYSIS CORP · Model 311UR-0100 · UDI-DI 00840937101940
LAF
Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
64
Facilities
Description
Methamphetamine Urine HEIA™
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-02-05 | OraSure Technologies, Inc. | Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labeling and the specification sheet listed the Substrate Reagent (TMB) lot 6676239, but |
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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.