FDA Device Intelligence
Home › MONOBIND, INC. › Anti-Tg AccuBind ELISA Test System - 96 Wells

Anti-Tg AccuBind ELISA Test System - 96 Wells

MONOBIND, INC. · Model 1025-300 · UDI-DI 00816870020389

DDC Prescription
1
510(k) clearances
1
Adverse events
1
Recalls
12
Facilities

Recalls

DateFirmReason
2006-10-26Beckman Coulter IncLow end imprecision affecting both S0 calibrators and patient samples which can lead to inaccurate low level patient results when using the Access Thyroglobulin Antibody assay.

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.