← FDA Medical Device Classifications

Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices

QLT · Not classified · Unknown

Classification

FDA Product Code
QLT
Device class
Not classified
Regulation
Review panel
MI
Medical specialty
Unknown
Submission type
8
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

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.

Market data

Cleared 510(k) submissions
0
Registered establishments
9

Source

Authoritative
FDA Device Classification database
Machine
JSON-LD · Markdown