Duns Number:296822794
Device Description: TSH - IMMULITE - RGT - 500 Tests
Catalog Number
LKRT5
Brand Name
IMMULITE®/IMMULITE® 1000 Systems RTH Rapid TSH
Version/Model Number
10381628
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K933212
Product Code
JLW
Product Code Name
RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
Public Device Record Key
a80c15c2-12b9-4f7a-8e94-420532b9f992
Public Version Date
November 18, 2021
Public Version Number
5
DI Record Publish Date
September 24, 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 | 143 |
2 | A medical device with a moderate to high risk that requires special controls. | 493 |
3 | A medical device with high risk that requires premarket approval | 22 |