TEST KIT, H PYLORI (10/KT)


Product Overview

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 Identifiers

Device 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


GMDN ®. © GMDN Agency 2005-2024.
Educational Resources
Videos