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DOA 1 PANEL TEST
RAPID DIAGNOSTICS INC · Model 07RD7060-05 · UDI-DI 00817830020692
LAF
Prescription
10
510(k) clearances
0
Adverse events
1
Recalls
64
Facilities
Description
Immunoassay for the detection of the following drug substance(s) in human urine: M-AMP
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.