Duns Number:317134468
Device Description: The DRG:Hybrid-XL DHEA is an enzyme immunoassay for the quantitative in vitro diagnostic m The DRG:Hybrid-XL DHEA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of DHEA in serum and plasma.
Catalog Number
HYE-5346
Brand Name
DHEA
Version/Model Number
HYE-5346
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)
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
a36db28e-8e60-4b31-b99a-e8d3faef17c8
Public Version Date
June 15, 2021
Public Version Number
1
DI Record Publish Date
June 07, 2021
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 | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |