FDA Device Intelligence
Home › DIAGNOSTIC HYBRIDS, INC. › D3 Ultra

D3 Ultra

DIAGNOSTIC HYBRIDS, INC. · Model 01-010000.V2 · UDI-DI 30014613330288

GNW Prescription
2
510(k) clearances
0
Adverse events
2
Recalls
7
Facilities

Description

D3 Ultra DFA Respiratory Virus Screening and ID kit

Recalls

DateFirmReason
2008-11-24Millipore CorporationCertain lots of Simulfluor Flu A / Flu B Reagent may cross-react with Respiratory Synctial Virus. The continued use of Simulfluor Flu A / Flu B Reagent Catalog #5250 may lead to a
2008-11-24Millipore CorporationCertain lots of Simulfluor Flu A / Flu B Reagent may cross-react with Respiratory Synctial Virus. The continued use of Simulfluor Flu A / Flu B Reagent Catalog #5250 may lead to a

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.