Duns Number:045623154
Device Description: FSH for the quantitative determination of FSH concentration in human serum. The assay is FSH for the quantitative determination of FSH concentration in human serum. The assay is useful in the diagnosis and treatment of pituitary and gonadal disorders. 96 Tests.
Catalog Number
F1029-96
Brand Name
Pointe Scientific, Inc.
Version/Model Number
F1029-96
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
CGJ
Product Code Name
Radioimmunoassay, Follicle-Stimulating Hormone
Public Device Record Key
27d5a5c8-10c7-42f8-a9c1-75f5f7e155b5
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 31, 2016
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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 455 |
| U | Unclassified | 2 |