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IDS-iSYS SDSpeed Calc
IMMUNODIAGNOSTIC SYSTEMS LIMITED · Model IS-SDSCALC · UDI-DI 05060169691148
OAM
Prescription
2
510(k) clearances
7
Adverse events
1
Recalls
12
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-11-23 | ACTIM OY | Interference testing has shown that the presence of personal lubricants in the vaginal specimen can interfere with the PROM test result by providing a false positive result. |
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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.