QUANTA Flash® dsDNA Reagents
Model 701178 · INOVA DIAGNOSTICS, INC. · DI 08426950624646
LSW — Anti-Dna Antibody, Antigen And Control · Class II · 21 CFR 866.5100
UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
No dated reports to chart.
Regulatory clearances
- K152013 SESE 2016-04-11 (k number procode)
Predicate lineage
K152013 — cites (transitively): K993727 (d1) — cited as predicate by K213403
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — INOVA DIAGNOSTICS, INC.
Nothing in the loaded window.