Last synced on 30 November 2024 at 11:09 am

Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices

Page Type
Product Code
Definition
Multi-analyte nucleic acid-based in vitro diagnostic devices for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), that causes COVID-19, and common respiratory microorganisms in human respiratory and/or acceptable clinical specimens collected from individuals suspected of respiratory viral infection consistent with COVID-19 by a healthcare provider. Results should not be used as the sole basis for diagnosis, treatment or other patient management decisions and must be combined with clinical observations, patient history, and/or epidemiological information.
Physical State
In Vitro Diagnostic Primers, Probes and/or capture oligos
Technical Method
Nucleic acid amplification and/or detection
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.
Review Panel
Microbiology
Submission Type
EUA - Emergency Use Authorization
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code QLT is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices

Page Type
Product Code
Definition
Multi-analyte nucleic acid-based in vitro diagnostic devices for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), that causes COVID-19, and common respiratory microorganisms in human respiratory and/or acceptable clinical specimens collected from individuals suspected of respiratory viral infection consistent with COVID-19 by a healthcare provider. Results should not be used as the sole basis for diagnosis, treatment or other patient management decisions and must be combined with clinical observations, patient history, and/or epidemiological information.
Physical State
In Vitro Diagnostic Primers, Probes and/or capture oligos
Technical Method
Nucleic acid amplification and/or detection
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.
Review Panel
Microbiology
Submission Type
EUA - Emergency Use Authorization
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code QLT is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.