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OTGClass II

Non-Sars Coronavirus Multiplex Nucleic Acid Assay

21 CFR 866.3980 / Microbiology
FDA source (opens on fda.gov)

OTG is the FDA product code for Non-Sars Coronavirus Multiplex Nucleic Acid Assay, a class II device type, regulated under 21 CFR 866.3980. FDA's definition for this code reads: "A non-SARS coronavirus multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of coronavirus 229E, coronavirus NL63, coronavirus HKU1 and Coronavirus OC43 nucleic acids isolated and purified from human respiratory specimens obtained from...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
OTG
Device name
Non-Sars Coronavirus Multiplex Nucleic Acid Assay
FDA definition
A non-SARS coronavirus multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of coronavirus 229E, coronavirus NL63, coronavirus HKU1 and Coronavirus OC43 nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of human non-SARS coronavirus nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract non-SARS coronavirus infections if used in conjunction with other clinical and laboratory findings.
Regulation
21 CFR 866.3980
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

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