Last synced on 30 November 2024 at 11:09 am

Coronavirus Antigen Detection Test System.

Page Type
Product Code
Definition
The qualitative detection of coronavirus viral antigens directly from clinical specimens.
Physical State
In vitro diagnostic device
Technical Method
Antigen detection
Target Area
Clinical specimens.
Review Panel
Microbiology
Submission Type
EUA - Emergency Use Authorization
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code QKP is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Coronavirus Antigen Detection Test System.

Page Type
Product Code
Definition
The qualitative detection of coronavirus viral antigens directly from clinical specimens.
Physical State
In vitro diagnostic device
Technical Method
Antigen detection
Target Area
Clinical specimens.
Review Panel
Microbiology
Submission Type
EUA - Emergency Use Authorization
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code QKP is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.