Duns Number:784143778
Device Description: This ELISA (enzyme-linked immunosorbent assay) kit is intended for the quantitative determ This ELISA (enzyme-linked immunosorbent assay) kit is intended for the quantitative determination of human Fetuin-A, also known as alpha-2-HS glycoprotein (AHSG), in serum, plasma (EDTA or Heparin), cell culture supernatant, tissue extracts and urine. The measurement of Fetuin-A in serum or plasma aids in the diagnosis of some cancers and genetically inherited deficiencies of this serum protein. This Fetuin-A ELISA kit is for in vitro diagnostic use.
Catalog Number
43-FETHU-E01
Brand Name
Fetuin-A ELISA
Version/Model Number
43-FETHU-E01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 09, 2020
Issuing Agency
In HIBCC
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
DEF
Product Code Name
Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control
Public Device Record Key
8cc2b1c6-ab4e-48b7-8a81-1ed0ddf6cd8a
Public Version Date
December 10, 2020
Public Version Number
2
DI Record Publish Date
September 25, 2020
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 | 42 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |