Duns Number:075150847
Device Description: The FSH ELISA is intended for the quantitative determination of FSH concentration in human The FSH ELISA is intended for the quantitative determination of FSH concentration in human serum. The assay is useful in the diagnosis and treatment of pituitary and gonadal disorders.
Catalog Number
EIA-1785
Brand Name
Follicle Stimulating Hormone (FSH) ELISA
Version/Model Number
EIA-1785
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
NGA
Product Code Name
TEST, FOLLICLE STIMULATING HORMONE (FSH), OVER THE COUNTER
Public Device Record Key
b89e45a3-cf60-4a3a-821f-81a685a11acf
Public Version Date
June 17, 2021
Public Version Number
1
DI Record Publish Date
June 09, 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 |