A rapid, automated, molecular test for the qualitative detection of COVID-19 viral nucleic acid in respiratory specimens.

A rapid, automated, molecular test for the qualitative detection of COVID
ID NOW™ COVID-19 - 190-000

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a nucleic acid technique (NAT). This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: QJR

Device Name: Reagents, 2019-Novel Coronavirus Nucleic Acid

Device Class: N

Physical State: In Vitro Diagnostic Primers, Probes and/or capture oligos.

Definition: Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens.

Submission Type ID: 8

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Nucleic acid amplification and/or detection.

Life Sustain Support Flag: N

Unclassified Reason: 11

Implant Flag: N

Target Area: The device is an in-vitro diagnostic device; none of the body parts will utilize the device or are intended to be affected by the device.

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 10811877011269

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