A rapid, automated, molecular test for the qualitative detection of COVID-19 viral nucleic acid in anterior nasal swab and nasopharyngeal swab specimens.

A rapid, automated, molecular test for the qualitative detection of COVID
ID NOW COVID-19 2.0 - 192-000

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.

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No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: QWR

Device Name: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

Device Class: 2

Physical State: An automated, instrument-based SARS-CoV-2 molecular IVD test.

Definition: A simple point-of-care device to detect SARS-CoV-2 nucleic acid targets directly from clinical specimens in near-patient settings is an in vitro diagnostic device for the direct detection of SARS-CoV-2 in clinical specimens and is intended as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19). The device is simple to use and does not involve sample manipulation, transportation of the sample to another functional area (e.g., a central laboratory or other specialized area), or measurement of reagents or analytes that could be affected by conditions such as sample turbidity or cell lysis. The design and procedures of the device are appropriate for use by healthcare professionals in near-patient settings outside a centralized laboratory.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Uses a molecular method to rapidly detect and identify SARS-CoV-2 nucleic acid targets in clinical specimens.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Clinical specimens from the respiratory system.

Regulation Number: 866.3982

Third Party Flag: N

Medical Specialty: MI

Device Id: 00811877011354

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