Duns Number:354019424
Device Description: Contains one vial of each Calibrator (Cal-0, Cal-0.3, Cal-1.5, Cal-5, Cal-15, Cal-80) to f Contains one vial of each Calibrator (Cal-0, Cal-0.3, Cal-1.5, Cal-5, Cal-15, Cal-80) to form a complete calibration curve for EliA IgA method.
Catalog Number
83-1013-01
Brand Name
EliA IgA Calibrators
Version/Model Number
83-1013-01
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
-
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
K062787
Product Code
MVM
Product Code Name
Autoantibodies, endomysial(tissue transglutaminase)
Public Device Record Key
c08fd17e-7dba-4998-844e-01d86820722c
Public Version Date
April 03, 2019
Public Version Number
1
DI Record Publish Date
March 26, 2019
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 | 225 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 518 |