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 ID: 08305900070255
• NIH Device Record Key: 065673f3-7f68-4d45-9bf2-7f127461e387
• Commercial Distribution Discontinuation: 2020-07-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: EPO [Erythropoietin] ELISA [Enzyme-Linked ImmunoSorbent Assay]
• Version Model Number: 7025
• Company DUNS: 067647321
• Company Name: BIOMERICA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08305900070255 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992799

FDA Product Code

• GGT: Assay, Erythropoietin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-09-02
• Device Publish Date: 2016-12-07

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

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