Duns Number:687910463
Device Description: It is used for the quantitative determination of Thyroid Stimulating Hormone in human spec It is used for the quantitative determination of Thyroid Stimulating Hormone in human specimen using FREND System.
Catalog Number
FRTS 025
Brand Name
FREND
Version/Model Number
FREND TSH
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
K131928
Product Code
JLW
Product Code Name
Radioimmunoassay, Thyroid-Stimulating Hormone
Public Device Record Key
5743c7cb-79b8-47e4-986a-4d829af57858
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 30, 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 | 21 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |