Duns Number:429447667
Device Description: 1. Antibody coated plate: 12-1 x 8 wells.2. Enzyme conjugate antibody (IgG):1x15mL vial.3. 1. Antibody coated plate: 12-1 x 8 wells.2. Enzyme conjugate antibody (IgG):1x15mL vial.3. Calibrators: 5 vials containing 1.5 ml human positive serum at five concentrations (2, 10, 20, 50 and 100 AU/ml).4. Control 1: 1x1.5 mL vial.5. Control 2: 1x1.5 mL vial.6. Sample Diluent (10x): 1 x20mL vial.7. Substrate: 1 x15 ml vial.8. Wash solution (20x): 1x50 mL vial.9. Stop Solution: 1 x15 ml vial.
Catalog Number
-
Brand Name
Eu-tTG IgG
Version/Model Number
9166
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
K102964
Product Code
MVM
Product Code Name
Autoantibodies, Endomysial(Tissue Transglutaminase)
Public Device Record Key
35b7d4b4-8166-44f8-b1cc-b6688055bbad
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 04, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |