EPO [Erythropoietin] ELISA [Enzyme-Linked ImmunoSorbent Assay]

GUDID 08305900070255

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.

BIOMERICA, INC.

Erythropoietin (EPO) IVD, reagent
Primary Device ID08305900070255
NIH Device Record Key065673f3-7f68-4d45-9bf2-7f127461e387
Commercial Distribution Discontinuation2020-07-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameEPO [Erythropoietin] ELISA [Enzyme-Linked ImmunoSorbent Assay]
Version Model Number7025
Company DUNS067647321
Company NameBIOMERICA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108305900070255 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GGTAssay, Erythropoietin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-09-02
Device Publish Date2016-12-07

On-Brand Devices [EPO [Erythropoietin] ELISA [Enzyme-Linked ImmunoSorbent Assay]]

00083059070255The Biomerica EPO ELISA is intended for the quantitative determination of Erythropoietin (EPO) i
08305900070255The Biomerica EPO ELISA is intended for the quantitative determination of Erythropoietin (EPO) i

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