E. Histolytica IgG ELISA EIA-3474

GUDID 00840239034748

The E. histolytica ELISA test is a qualitative enzyme immunoassay for the detection of antibodies to E. histolytica, in samples of human serum or plasma.

DRG International Inc

Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00840239034748
• NIH Device Record Key: 927a36a2-859d-4ccb-908c-9d3e267c8b7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E. Histolytica IgG ELISA
• Version Model Number: EIA-3474
• Catalog Number: EIA-3474
• Company DUNS: 075150847
• Company Name: DRG International 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(973)564-7555
• Email: corp@drg-international.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840239034748 [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: 2
• Public Version Date: 2020-03-30
• Device Publish Date: 2019-03-20

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