Duns Number:075150847
Device Description: For the direct quantitative determination of Pregnenolone by an enzyme immunoassay in huma For the direct quantitative determination of Pregnenolone by an enzyme immunoassay in human serum.
Catalog Number
EIA-4912
Brand Name
Pregnenolone ELISA
Version/Model Number
EIA-4912
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
JNG
Product Code Name
RADIOIMMUNOASSAY, PREGNENOLONE
Public Device Record Key
1642cf7d-96b7-47c2-8f7c-c2d01bd3eb84
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |