Duns Number:045623154
Device Description: Testosterone for the quantitative determination of testosterone concentration in human ser Testosterone for the quantitative determination of testosterone concentration in human serum. For in vitro diagnostic use only. 96 Tests.
Catalog Number
S1115-96
Brand Name
Pointe Scientific, Inc.
Version/Model Number
S1115-96
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
K002294
Product Code
CDZ
Product Code Name
Radioimmunoassay, Testosterones And Dihydrotestosterone
Public Device Record Key
eef277fc-02a2-4ac1-aef6-aa7a99a39450
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 31, 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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 455 |
| U | Unclassified | 2 |