Duns Number:540156544
Device Description: Time-resolved fluoroimmunoassay for the quantitative determination of human Inhibin A.
Catalog Number
B064-112-P2
Brand Name
AutoDELFIA Inhibin A kit Level Calibrators
Version/Model Number
B064-112-P2
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
NDR
Product Code Name
Enzyme Immunoassay, Inhibin-A
Public Device Record Key
e81e521d-de46-4249-a095-52db0b96269c
Public Version Date
December 24, 2018
Public Version Number
1
DI Record Publish Date
November 21, 2018
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 | 57 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |
| 3 | A medical device with high risk that requires premarket approval | 2 |