Duns Number:989964119
Device Description: Alinity i TSH Reagent Kit 1200 Tests
Catalog Number
07P4830
Brand Name
Alinity
Version/Model Number
07P4830
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
b4937e1a-fd26-4306-bc28-520dbc5c0491
Public Version Date
December 02, 2020
Public Version Number
2
DI Record Publish Date
July 31, 2018
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 | 110 |
2 | A medical device with a moderate to high risk that requires special controls. | 101 |