Duns Number:064608573
Device Description: ADVIA Centaur® Testosterone (TSTO) Assay Kit 50T
Catalog Number
11201912
Brand Name
ADVIA Centaur® TSTO
Version/Model Number
11201912
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 12, 2020
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CDZ
Product Code Name
RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE
Public Device Record Key
479fb258-8fd7-4eee-93ef-b6ccd1367498
Public Version Date
November 18, 2021
Public Version Number
2
DI Record Publish Date
August 12, 2020
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 | 363 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 829 |
| 3 | A medical device with high risk that requires premarket approval | 57 |
| U | Unclassified | 7 |