Home › Immunostics Company, Inc › Detector Lex SLE
Detector Lex SLE
Immunostics Company, Inc · Model SLE-100 · UDI-DI 10722355001729
DHC
Prescription
10
510(k) clearances
0
Adverse events
1
Recalls
5
Facilities
Description
A rapid undiluted latex agglutination slide test for the detection of anti-nucleoprotein serum factors associated with systemic lupus erythematosus (sLE)
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.