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

Coronavirus Antigen Detection Test System.

Unknown
FDA source (opens on fda.gov)

QKP is the FDA product code for Coronavirus Antigen Detection Test System. FDA's definition for this code reads: "The qualitative detection of coronavirus viral antigens directly from clinical specimens". As of , FDA records hold no 510(k) clearances under this code and 47 recalls.

Classification record

Product code
QKP
Device name
Coronavirus Antigen Detection Test System.
FDA definition
The qualitative detection of coronavirus viral antigens directly from 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
47

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 66 companies shown, in name order