Duns Number:008254708
Device Description: The Access hFSH Calibrators are intended to calibrate the Access hFSH assay for the quanti The Access hFSH Calibrators are intended to calibrate the Access hFSH assay for the quantitative determination offollicle stimulating hormone (FSH) levels in human serum and plasma using the Access Immunoassay Systems.
Catalog Number
33525
Brand Name
Access hFSH Calibrators
Version/Model Number
33525
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
37e04175-a563-4b81-8284-d0028f837458
Public Version Date
September 13, 2021
Public Version Number
1
DI Record Publish Date
September 03, 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 | 319 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 503 |
| 3 | A medical device with high risk that requires premarket approval | 9 |
| U | Unclassified | 1 |