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

Reagent, Coronavirus Serological

Unknown
FDA source (opens on fda.gov)

QKO is the FDA product code for Reagent, Coronavirus Serological. FDA's definition for this code reads: "The qualitative detection of IgM and/or IgG antibodies to coronavirus from human specimens". As of , FDA records hold no 510(k) clearances under this code and 31 recalls.

Classification record

Product code
QKO
Device name
Reagent, Coronavirus Serological
FDA definition
The qualitative detection of IgM and/or IgG antibodies to coronavirus from human 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
31

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 50 companies shown, in name order