Home › INOVA DIAGNOSTICS, INC. › QUANTA Lite® R h-tTG IgG ELISA Bulk Pack

QUANTA Lite® R h-tTG IgG ELISA Bulk Pack

INOVA DIAGNOSTICS, INC. · Model 704610.10 · UDI-DI 08426950594161

MVM Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

1. Instruction leaflet: Giving full assay details. 2. QC Certificate: Indicating the expected performance of the batch. 3. Human Transglutaminase Coated Wells: 10 plates containing 12 breakapart 8 well strips coated with recombinant tTG. Each plate is packaged in a re-sealable foil bag containing two desiccant pouches. 4. HRP Sample Diluent: 19 bottles containing 50mL of buffer for sample dilution. Colored pink, ready to use. 5. HRP Wash Concentrate: 10 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells. 6. R h-tTG IgG Calibrators: 25 bottles (5 bottles each), containing 1.2mL of diluted human serum, with the following concentrations of anti-tTG IgG autoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL. Ready to use. 7. R h-tTG IgG Positive Control: 5 bottles containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use. 8. ELISA Negative Control: 5 bottles containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use. 9. HRP R h-tTG IgG Conjugate: 10 bottles containing 10mL of purified peroxidase labelled antibody to human IgG. Colored blue. Ready to use. 10. TMB Chromogen: 10 bottles containing 10mL TMB chromogen. Ready to use. 11. Stop Solution: 10 bottles containing 10mL of 0.344M Sulfuric Acid. Ready to use.

Recalls

Date	Firm	Reason
2019-04-03	Bio-Rad Labs	An elevated lot-to-lot bias was observed for Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA when compared to a previous lot of product. The observed elevated bias between th

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.