Coronavirus Antigen Detection Test System.
The Coronavirus Antigen Detection Test System is a not-classified in vitro diagnostic device intended for the qualitative detection of coronavirus viral antigens directly from clinical specimens, used in the context of the COVID-19 public health emergency. It has no assigned regulation number and is reviewed by the Microbiology panel. The product code is QKP. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QKP
- Device Class
- FDA not classified
- Medical Specialty
- Unknown
- Review Panel
- MI
- Submission Type
- 8
Device Characteristics
Definition
The qualitative detection of coronavirus viral antigens directly from clinical specimens.
Unclassified Reason
11
FEI Numbers
This FDA classification entry is associated with 83 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 83 registration numbers. Click on an entry to view related FDA registrations.