Duns Number:261769626
Device Description: Radioimmunometric assay kit for the quantitative determination of progesterone in human sa Radioimmunometric assay kit for the quantitative determination of progesterone in human samples. Contain enough reagents for 100 tests. For in vitro diagnostic.
Catalog Number
PROGEST-US
Brand Name
PROGEST-US
Version/Model Number
PROGEST-US
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
-
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
JLS
Product Code Name
Radioimmunoassay, Progesterone
Public Device Record Key
fcf972e8-a467-4b12-9830-1ec302355020
Public Version Date
December 15, 2021
Public Version Number
1
DI Record Publish Date
December 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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |