Echinococcus Antibody 96 Tests EG-96

GUDID 00813545025380

SCIMEDX CORPORATION

Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00813545025380
• NIH Device Record Key: 83a2c335-ca42-4d52-87ab-e44064331c5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Echinococcus Antibody 96 Tests
• Version Model Number: EG-96
• Catalog Number: EG-96
• 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	00813545025380 [Primary]

FDA Product Code

• GPD: Antigen, Indirect Fluorescent Antibody Test, Echinococcus Granulosus

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

Devices Manufactured by SCIMEDX CORPORATION

• 00813545023843 - ProSorb-G 2 ml 50 Test: 2023-06-21 IgG Removal Reagent
• 00813545029029 - GBM IgG Test System: 2023-06-21
• 00813545029036 - MBO IgG Test System: 2023-06-21
• 00813545029043 - PR3 IgG Test System: 2023-06-21
• 00813545026561 - MeDiCa: 2020-12-09 Rat Liver 4 Well Slide (each)
• 00813545026578 - MeDiCa: 2020-12-09 Rat Liver 8 Well Slide (each)
• 00813545026585 - MeDiCa: 2020-12-09 Crithidia luciliae 4 Well Slide (each)
• 00813545026592 - MeDiCa: 2020-12-09 Crithidia luciliae 8 Well Slide (each)