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Optilite C1 Inactivator Kit

THE BINDING SITE GROUP LIMITED · Model NK019.OPT.A · UDI-DI 05051700017589

DBA Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
5
Facilities

Recalls

DateFirmReason
2023-02-01Quidel CorporationKits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.