Duns Number:181070814
Device Description: A radioimmunoassay for the quantitative or qualitative determination of antibodies to the A radioimmunoassay for the quantitative or qualitative determination of antibodies to the thyroid stimulating hormone (TSH) receptor in human serum.
Catalog Number
KR7060
Brand Name
TSH RECEPTOR ANTIBODY (TRAb) COATED TUBE (CT) ASSAY KIT
Version/Model Number
KR7060
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K032134
Product Code
JZO
Product Code Name
System, Test, Thyroid Autoantibody
Public Device Record Key
5b698295-c2a4-4d28-a1c3-ace539b2499d
Public Version Date
September 24, 2018
Public Version Number
4
DI Record Publish Date
September 23, 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. | 24 |