FDA Device Intelligence
Home › THE BINDING SITE GROUP LIMITED › Human C3c Kit for use on the SPAplus

Human C3c Kit for use on the SPAplus

THE BINDING SITE GROUP LIMITED · Model NK023.S · UDI-DI 05051700015578

CZW Prescription
1
510(k) clearances
3
Adverse events
1
Recalls
33
Facilities

Recalls

DateFirmReason
2018-05-16Abbott Laboratories, IncAn update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.

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.