Helicobacter pylori IgG Ab - IMMULITE - RGT - 200 Tests

Helicobacter pylori IgG Ab
IMMULITE® 2000 Systems HPG H.pylori IgG - 10381336

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 Helicobacter pylori bacteria in a clinical specimen, using a chemiluminescent immunoassay method. Infection with H. pylori is associated with gastroduodenal disorders such as active chronic gastritis, gastric, and duodenal ulcers.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 00630414961637

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