E.histolytica Antibody 96 Test with Calibrator EH-96C

GUDID 00813545025403

SCIMEDX CORPORATION

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

• Primary Device ID: 00813545025403
• NIH Device Record Key: d03272dd-314b-4e90-ac28-3ddcdc989b78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E.histolytica Antibody 96 Test with Calibrator
• Version Model Number: EH-96C
• Catalog Number: EH-96C
• Company DUNS: 155424708
• Company Name: SCIMEDX CORPORATION
• 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: true
• 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: 18002215598
• Email: service@scimedx.com
• Phone: 18002215598
• Email: service@scimedx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813545025403 [Primary]

FDA Product Code

• GWD: Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-20

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