E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay]

GUDID 00083059070781

The Biomerica E. histolytica/dispar ELISA is intended for the qualitative detection of Entamoeba specific antigen in fecal specimens. This assay is intended for in vitro diagnostic use only.

BIOMERICA, INC.

Entamoeba histolytica antigen IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00083059070781
• NIH Device Record Key: 7b263525-a8c6-4290-a1be-3133a83074f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay]
• Version Model Number: 7078
• Company DUNS: 067647321
• Company Name: BIOMERICA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
• 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	00083059070781 [Primary]

FDA Product Code

• KHW: Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-09
• Device Publish Date: 2020-07-01

On-Brand Devices [E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay]]

• 00083059070781: The Biomerica E. histolytica/dispar ELISA is intended for the qualitative detection of Entamoeba
• 08305900070781: The Biomerica E. histolytica/dispar ELISA is intended for the qualitative detection of Entamoeba