Home › INOVA DIAGNOSTICS, INC. › QUANTA Lite® Centromere ELISA
QUANTA Lite® Centromere ELISA
INOVA DIAGNOSTICS, INC. · Model 708770 · UDI-DI 08426950544128
LJM
Prescription
1
510(k) clearances
0
Adverse events
2
Recalls
26
Facilities
Description
(CENP-A & CENP-B) 1.1x Centromere ELISA microwell plate (12-1 x 8 wells), with holder 2.1x 1.2mL prediluted ELISA Negative Control 3.1x 1.2mL prediluted Centromere ELISA Low Positive 4.1x 1.2mL prediluted Centromere ELISA High Positive 5.1x 50mL HRP Sample Diluent 6.1 x25mL 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 |
|---|---|---|
| 2008-08-27 | Calbiotech Inc | The recall was initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. The firm reported although there is no potential health hazard related to |
| 2008-08-19 | Zeus Scientific Inc | The Calibrator Value is printed incorrectly on the Sm ELISA Test System, lot # 08041819. The Calibrator Value (CV) printed on the label is 102; the correct CV should read 266. |
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 docsData 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.