Duns Number:784143778
Device Description: The DHEA-S ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measure The DHEA-S ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of DHEA-S in serum and plasma.
Catalog Number
20-DHSHU-E01
Brand Name
DHEA-S ELISA
Version/Model Number
20-DHSHU-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
-
Product Code
JKC
Product Code Name
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
Public Device Record Key
878886a9-86e6-4e4e-abce-adf1a1679ca5
Public Version Date
September 19, 2022
Public Version Number
1
DI Record Publish Date
September 09, 2022
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 |