Duns Number:067647321
Device Description: The Biomerica EPO ELISA is intended for the quantitative determination of Erythropoietin ( The Biomerica EPO ELISA is intended for the quantitative determination of Erythropoietin (EPO) in human serum. This assay is intended for in vitro diagnostic use, as an aid in the diagnosis of anemias and polycythemias. With the advent of the administration of recombinant erythropoietin as a biologic therapy to increase red blood cell mass, an erythropoietin assay may be used also to aid in the prediction and monitoring of response to recombinant erythropoietin treatment in persons with anemias.
Catalog Number
-
Brand Name
EPO [Erythropoietin] ELISA [Enzyme-Linked ImmunoSorbent Assay]
Version/Model Number
7025
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 01, 2020
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K992799
Product Code
GGT
Product Code Name
Assay, Erythropoietin
Public Device Record Key
065673f3-7f68-4d45-9bf2-7f127461e387
Public Version Date
September 02, 2021
Public Version Number
4
DI Record Publish Date
December 07, 2016
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35 |