Control Swabs intended for use only with the ID NOW™ COVID
ID NOW™ COVID-19 Control Swab Kit - 190-080
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 10811877011276
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
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