Last synced on 6 December 2024 at 11:05 pm

Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection

Page Type
Product Code
Definition
The device is a qualitative, in vitro diagnostic test for the direct detection of Cytomegalovirus (CMV) DNA in saliva from newborn babies.
Physical State
In vitro diagnostic device
Technical Method
Qualitative DNA amplification technology
Target Area
Human clinical specimens
Regulation Medical Specialty
Microbiology
Review Panel
Microbiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
866.3181
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

Product code QDZ is linked to regulation 21CFR866.3181, which does not seem to exist yet. It may be pending at the moment.

Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection

Page Type
Product Code
Definition
The device is a qualitative, in vitro diagnostic test for the direct detection of Cytomegalovirus (CMV) DNA in saliva from newborn babies.
Physical State
In vitro diagnostic device
Technical Method
Qualitative DNA amplification technology
Target Area
Human clinical specimens
Regulation Medical Specialty
Microbiology
Review Panel
Microbiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
866.3181
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

Product code QDZ is linked to regulation 21CFR866.3181, which does not seem to exist yet. It may be pending at the moment.