Duns Number:171857493
Device Description: The BioCheck Testosterone EIA Test Kit is intended for the quantitative determination of t The BioCheck Testosterone EIA Test Kit is intended for the quantitative determination of testosterone concentration in human serum.
Catalog Number
BC-1115
Brand Name
BioCheck Testosterone EIA Test Kit
Version/Model Number
BC-1115
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
K002294
Product Code
CDZ
Product Code Name
Radioimmunoassay, Testosterones And Dihydrotestosterone
Public Device Record Key
f8a32cfb-a3aa-427a-a35b-e625378f0e5e
Public Version Date
August 07, 2019
Public Version Number
1
DI Record Publish Date
July 30, 2019
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |