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Elecsys AMH
Roche Diagnostics GmbH · Model 08819378190 · UDI-DI 07613336166291
PQO
Prescription
1
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. |
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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.