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QUANTA Lite® M2 EP (MIT3) ELISA

INOVA DIAGNOSTICS, INC. · Model 704540 · UDI-DI 08426950593119

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510(k) clearances

Adverse events

Recalls

Facilities

Description

1. 1 M2 EP (MIT3) ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted M2 EP (MIT3) ELISA Low Positive 4. 1x 1.2mL prediluted M2 EP (MIT3) ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid

Recalls

Date	Firm	Reason
2008-07-29	Bio-Rad Laboratories	The Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128 reported on the QC Report Label included with each test kit.
2004-04-12	Diasorin Inc.	The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800 reader) was found to be faulty. This program is used to calculate the cut o

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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.