Duns Number:784143778
Device Description: The 17-α-OH Progesterone ELISA is an enzyme immunoassay for the quantitative in vitro diag The 17-α-OH Progesterone ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-α-OH Progesterone (17-α-OHP) in serum or plasma (EDTA, heparin, or citrate). For in vitro diagnostic use.
Catalog Number
20-17OHU-E01
Brand Name
17-alpha Hydroxy Progesterone ELISA
Version/Model Number
20-17OHU-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
JLX
Product Code Name
Radioimmunoassay, 17-Hydroxyprogesterone
Public Device Record Key
408bf3fc-7170-4b40-9e28-7c6ea2d19918
Public Version Date
June 26, 2020
Public Version Number
1
DI Record Publish Date
June 18, 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 |