FDA Device Intelligence
Home › Minaris Medical America, Inc. › OPTIGEN® Allergen-Specific IgE Assay - US Environmental 36 (40ND)

OPTIGEN® Allergen-Specific IgE Assay - US Environmental 36 (40ND)

Minaris Medical America, Inc. · Model 85168 · UDI-DI 00813382012178

PUW Prescription
0
510(k) clearances
0
Adverse events
0
Recalls
6
Facilities

Description

KIT, OPTIGEN US Environmental 36 (40ND)

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.