Duns Number:188354831
Device Description: 1. Instruction leaflet: Giving full assay details. 2. QC Certificate: Indicating the 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.
Catalog Number
-
Brand Name
QUANTA Lite® R h-tTG IgG ELISA Bulk Pack
Version/Model Number
704610.10
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K040466
Product Code
MVM
Product Code Name
Autoantibodies, Endomysial(Tissue Transglutaminase)
Public Device Record Key
36547740-a27c-4c9c-8fc2-1c78b8148e04
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 31, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 215 |