Simplexa COVID-19 Direct

Simplexa COVID-19 Direct - MOL4150

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 severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent for COVID-19, in a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: QQX

Device Name: Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

Device Class: 2

Physical State: A test system that contains all necessary reagents for sample preparation, nucleic acid reverse transcription and amplification, and detection from SARS-CoV-2 nucleic acids from a single respiratory tract specimen.

Definition: A device to detect and identify nucleic acid targets in respiratory specimens from SARS-CoV-2 that cause COVID-19 is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 nucleic acid targets in human clinical respiratory specimens from patients suspected of COVID-19 based on signs and symptoms of respiratory infections by their healthcare providers. The device is intended to aid in the diagnosis of COVID-19 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).

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Human respiratory tract specimens, such as anterior nasal swabs, nasopharyngeal swabs, nasal or nasopharyngeal washes and aspirates, etc.

Regulation Number: 866.3981

Third Party Flag: N

Medical Specialty: MI

Device Id: 20816101027020

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