Duns Number:784143778
Device Description: Intended for the direct quantitative determination of Testosterone by an enzyme immunoassa Intended for the direct quantitative determination of Testosterone by an enzyme immunoassay in human serum. For in vitro diagnostic use.
Catalog Number
11-TESHU-E01
Brand Name
Serum Testosterone ELISA
Version/Model Number
11-TESHU-E01
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K014120
Product Code
CDZ
Product Code Name
Radioimmunoassay, Testosterones And Dihydrotestosterone
Public Device Record Key
cb5140b0-bc22-4167-b012-9b65556b0d3a
Public Version Date
October 05, 2020
Public Version Number
1
DI Record Publish Date
September 25, 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 | 42 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |