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AccuDiag ™
Diagnostic Automation, Inc. · Model DACD351-50 · UDI-DI 00850049545907
10
510(k) clearances
0
Adverse events
1
Recalls
5
Facilities
Description
AccuDiag ™ SLE Latex Test Kit is a latex slide agglutination assay for the qualitative and semiquantitative detection of anti-deoxyribonucleoprotein (anti-DNP) in human serum
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2009-07-14 | Bio-Rad Laboratories Inc | The firm received customer complaints of microbial contamination in Positive Controls in its Anti-Cardiolipin IgM Test Kit Lot CL-863. |
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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.