510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QJRNot classified

Reagents, 2019-Novel Coronavirus Nucleic Acid

Unknown
FDA source (opens on fda.gov)

QJR is the FDA product code for Reagents, 2019-Novel Coronavirus Nucleic Acid. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and 40 recalls.

Classification record

Product code
QJR
Device name
Reagents, 2019-Novel Coronavirus Nucleic Acid
FDA 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.
Device class
Not classified
Review panel
Unknown
Submission type
FDA code 8
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
40

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 49 companies shown, in name order