Duns Number:188354831
Device Description: 1. 10x Gliadin IgG II ELISA Plate2. 5x 1.2mL Gliadin IgG II ELISA Low Positive3. 5x 1.2mL 1. 10x Gliadin IgG II ELISA Plate2. 5x 1.2mL Gliadin IgG II ELISA Low Positive3. 5x 1.2mL Gliadin IgG II ELISA High Positive4. 10x 10mL HRP IgG Conjugate5. 10x 10mL TMB Chromogen6. 10x 10mL HRP Stop Solution7. 9 x50mL HRP Sample Diluent8. 10x 25mL HRP Wash Concentrate, 40x concentrate9. 5x 1.2mL ELISA Negative Control
Catalog Number
-
Brand Name
QUANTA LITE® Gliadin IgG II ELISA Bulk Pack (Lab Corp)
Version/Model Number
704520.10L
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
K052142
Product Code
MST
Product Code Name
Antibodies, Gliadin
Public Device Record Key
91d18935-d740-4770-8edf-1d5f3a0c7e46
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
August 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 |