Echinococcus Antibody 96 Tests

Basic Information

• Brand Name: Echinococcus Antibody 96 Tests
• Primary DI: 00813545025380
• Version / Model: EG-96
• Catalog Number: EG-96
• Company Name: SCIMEDX CORPORATION
• Labeler DUNS: 155424708
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 83a2c335-ca42-4d52-87ab-e44064331c5e

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GPD	Antigen, Indirect Fluorescent Antibody Test, Echinococcus Granulosus	Microbiology	866.3200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
52219	Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Echinococcus granulosus and/or Echinococcus multilocularis in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with the parasitic tapeworms associated with hydatid disease.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813545025380	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]