Duns Number:215865786
Device Description: VITROS Immunodiagnostic Products Total T3 Reagent Pack
Catalog Number
1322528
Brand Name
VITROS
Version/Model Number
1322528
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
-
Product Code
CDP
Product Code Name
RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
Public Device Record Key
e5b181b6-0ec1-4e13-8917-1ca79bb70e2e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 10, 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 | 64 |
2 | A medical device with a moderate to high risk that requires special controls. | 76 |
3 | A medical device with high risk that requires premarket approval | 17 |