Duns Number:251005005
Device Description: Rapid Response FSH Menopause Test Cassette (Urine) - 25 tests/ kit for the qualitative det Rapid Response FSH Menopause Test Cassette (Urine) - 25 tests/ kit for the qualitative detection of Follicle-stimulating hormone in urine.
Catalog Number
-
Brand Name
Rapid Response
Version/Model Number
FSH-1C25
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)
Yes
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
71028fe4-dd36-4003-8159-c2fda98ac904
Public Version Date
July 02, 2021
Public Version Number
1
DI Record Publish Date
June 24, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |