IVD reagent kit containing 6 tests

IVD reagent kit containing 6 tests
FilmArray® Pneumonia Panel (Pneumo) - RFIT-ASY-0145

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 (bacteria, fungi and/or viruses) associated with respiratory disease in a clinical specimen, using a nucleic acid technique (NAT). Organisms detected may include (but are not limited to) Streptococcus pneumoniae, influenza A, respiratory syncytial viruses A and B, rhinovirus, Haemophilus influenzae, Mycoplasma pneumoniae, Staphylococcus aureus, and/or enterovirus.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: QDP

Device Name: Respiratory Panel

Device Class: 2

Physical State: Multiplex nucleic acid panel

Definition: The panel is a multiplexed nucleic acid test intended for use with systems for the simultaneous detection and identification of multiple respiratory viral and bacterial nucleic acids, as well as select antimicrobial resistance genes, in sputum-like specimens (induced or expectorated sputum, or endotracheal aspirates) or bronchoalveolar lavage (BAL)-like specimens (BAL or mini-BAL) obtained from individuals suspected of lower respiratory tract infection.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Semi-quantitative multiplexed nucleic acid test

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Human clinical samples

Regulation Number: 866.3985

Third Party Flag: N

Medical Specialty: MI

Device Id: 00815381020185

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