E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay]

GUDID 08305900070781

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.

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• Primary Device ID: 08305900070781
• NIH Device Record Key: 6ca1c311-2dd5-47db-80bd-2980c1bf4eb2
• Commercial Distribution Discontinuation: 2020-07-01
• Commercial Distribution Status: Not 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08305900070781 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-09-02
• Device Publish Date: 2016-12-08

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