ACCUTEST H. Pylori Rapid Test Device (Whole Blood/Serum) *CLIA-Waived*


Product Overview

ACCUTEST H. Pylori Rapid Test Device (Whole Blood/Serum) *CLIA
ACCUTEST H. Pylori Rapid Test Device (Whole Blood/Serum) *CLIA-Waived* - ID392


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from Helicobacter pylori bacteria in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to detect infection with H. pylori which is associated with gastroduodenal disorders such as active chronic gastritis and gastric/duodenal ulcers. It is not intended to be used for self-testing.


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: 10763924392206

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: 00726924392204

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


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