Duns Number:075150847
Device Description: The Ferritin ELISA is intended for the quantitative determination of ferritin in human ser The Ferritin ELISA is intended for the quantitative determination of ferritin in human serum. This assay is to be used in the diagnosis of diseases affecting iron metabolism.
Catalog Number
EIA-1872
Brand Name
Ferritin ELISA
Version/Model Number
EIA-1872
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K992517
Product Code
DBF
Product Code Name
FERRITIN, ANTIGEN, ANTISERUM, CONTROL
Public Device Record Key
bed28e5a-9f02-4bfe-b323-60e19981aacf
Public Version Date
March 30, 2020
Public Version Number
2
DI Record Publish Date
March 20, 2019
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |