Duns Number:276816717
Device Description: VIDAS TSH assay is intended for the determination of human TSH concentration in human seru VIDAS TSH assay is intended for the determination of human TSH concentration in human serum or plasma as an aid in the diagnosis of thyroid or pituitary disorders.
Catalog Number
-
Brand Name
VIDAS® TSH
Version/Model Number
30400-01
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
-
Product Code
JLW
Product Code Name
Radioimmunoassay, Thyroid-Stimulating Hormone
Public Device Record Key
6e64d97d-7dc7-4ff8-a17e-fbea9491013b
Public Version Date
December 19, 2018
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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 156 |
| 3 | A medical device with high risk that requires premarket approval | 3 |