Panther Fusion® SARS-CoV-2/Flu A/B/RSV Assay Controls Kit.

Panther Fusion® SARS
Panther Fusion® - KIT, SARS/FLU A/B/RSV CONTROLS, FUSION, IVD

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple virus genera associated with respiratory disease in a clinical specimen. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: QOF

Device Name: Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

Device Class: 2

Physical State: A closed system disposable pouch that contains all necessary reagents for sample preparation, reverse transcription, polymerase chain reaction (PCR), and detection from multiple respiratory pathogens from a single nasopharyngeal swab specimen. The reagent pouch is hydrated with sample buffer and specimen to activate and is placed into an automated instrument to perform the sample preparation, PCR reaction, and detection for result generation.

Definition: A device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 and other microbial agents when in a multi-target test in human clinical respiratory specimens from patients suspected of respiratory infection who are at risk for exposure or who may have been exposed to these agents. The device is intended to aid in the diagnosis of respiratory infection in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: A nucleic acid amplification test (NAAT). PCR-based.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Nasopharyngeal (i.e., upper respiratory) swab specimen.

Regulation Number: 866.3981

Third Party Flag: N

Medical Specialty: MI

Device Id: 15420045515376

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