IVD reagent kit containing 6 tests.

IVD reagent kit containing 6 tests.
FilmArray® Gastrointestinal (GI) Panel - RFIT-ASY-0104

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms associated with gastrointestinal disease, in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include bacteria, viruses, fungi and/or parasites such as, but are not limited to Salmonella, Shigella, Campylobacter, Escherichia coli (E. coli), Norovirus, Rotavirus, Clostridium difficile, Giardia, Bacillus and/or Vibrio species.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PCH

Device Name: Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

Device Class: 2

Physical State: Gastrointestinal pathogen panel multiplex nucleic acid-based assay systems are devices that consist of reagents and instruments for the simultaneous detection and identification of multiple gastrointestinal microbial nucleic acids extracted from human stool specimens.

Definition: A gastrointestinal pathogen panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: A qualitative in vitro diagnostic assay intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: In vitro diagnostic device

Regulation Number: 866.3990

Third Party Flag: N

Medical Specialty: MI

Device Id: 00815381020116

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