Home › INOVA DIAGNOSTICS, INC. › QUANTA Lite® β2GPI Screening ELISA

QUANTA Lite® β2GPI Screening ELISA

INOVA DIAGNOSTICS, INC. · Model 708660 · UDI-DI 08426950454472

MSV Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

1. 1x β2 GPI Screen ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted β2 GPI Decision Point 4. 1x 1.2mL prediluted β2 GPI Screening Control 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgGAM Conjugate, (goat), anti-human 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid

Recalls

Date	Firm	Reason
2004-10-26	Diasorin Inc.	Data reduction Program written for specific sutomated microtiter plate insturment (Bio-Tek ELx800 reader) is faulty in that the positive result limit is to be greater than 15 U/ml,

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 key Read 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.