Home › MONOBIND, INC. › AMH AccuLite CLIA Test System - 96 Wells
AMH AccuLite CLIA Test System - 96 Wells
MONOBIND, INC. · Model 9775-300 · UDI-DI 00816870023786
PQO
Prescription
5
510(k) clearances
14
Adverse events
1
Recalls
9
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
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 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.