FDA Device Intelligence
HomeIMMUNODIAGNOSTIC SYSTEMS LIMITED › IDS-iSYS Insulin like Growth Factor-1 (IGF-1)

IDS-iSYS Insulin like Growth Factor-1 (IGF-1)

IMMUNODIAGNOSTIC SYSTEMS LIMITED · Model IS-3900 · UDI-DI 05060169690288

OAM Prescription
2
510(k) clearances
7
Adverse events
1
Recalls
12
Facilities

Recalls

DateFirmReason
2023-11-23ACTIM OYInterference 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.

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 docs
Data 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.