"720
Diamedix - 720-640
Device Description
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 in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Echinococcus granulosus, the parasitic tapeworm associated with hydatid disease.
Environmental Conditions
- 8.00
- 2.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: GNP
Device Name: Antiserum, Cf, Epstein-Barr Virus
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: MI
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 866.3235
Third Party Flag: Y
Medical Specialty: MI
Device IdentifiersDevice Id: 00817273020358
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A