TEST KIT, H PYLORI (10/KT)
McKesson - 181-37010
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to Helicobacter pylori bacteria in a clinical specimen, using an enzyme immunoassay (EIA) method.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: LYR
Device Name: Helicobacter Pylori
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: 866.3110
Third Party Flag: Y
Medical Specialty: MI
Device IdentifiersDevice Id: 00612479261488
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00612479261471
Package Quantity: 15
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case
Device Id: 00612479261471
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
Device Id: 00612479261464
Device Type: Unit of Use
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