FDA Device Intelligence
HomeINOVA DIAGNOSTICS, INC. › QUANTA Lite® aPS/PT IgG ELISA

QUANTA Lite® aPS/PT IgG ELISA

INOVA DIAGNOSTICS, INC. · Model 708835 · UDI-DI 08426950594864

OPN Prescription
1
510(k) clearances
0
Adverse events
0
Recalls
2
Facilities

Description

(anti-phosphatidylserine and prothrombin) 1x aPS/PT IgG ELISA microwell plate (12-1 x 8 wells), with holder 1x 1.2mL prediluted ELISA Negative Control 1x 1.2mL prediluted aPS/PT IgG ELISA Control 1x 1.2mL prediluted aPS/PT IgG ELISA Calibrator A 1x 1.2mL prediluted aPS/PT IgG ELISA Calibrator B 1x 1.2mL prediluted aPS/PT IgG ELISA Calibrator C 1x 1.2mL prediluted aPS/PT IgG ELISA Calibrator D 1x 1.2mL prediluted aPS/PT IgG ELISA Calibrator E 1x 10mL HRP aPS/PT IgG Conjugate, (goat), anti-human IgG 1x 50mL HRP Sample Diluent Plus 1x 25mL HRP Wash Buffer Plus, 40x concentrate 1x 10mL TMB Chromogen 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid

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.