Last synced on 30 November 2024 at 11:09 am

Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies

Page Type
Product Code
Definition
Intended for the detection of IgM and IgG antibodies to dengue virus in human serum, plasma or whole blood.
Physical State
In-vitro diagnositc test
Technical Method
In-vitro diagnostic test
Target Area
In-vitro diagnostic test
Review Panel
Microbiology
Submission Type
Contact ODE
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

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

Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies

Page Type
Product Code
Definition
Intended for the detection of IgM and IgG antibodies to dengue virus in human serum, plasma or whole blood.
Physical State
In-vitro diagnositc test
Technical Method
In-vitro diagnostic test
Target Area
In-vitro diagnostic test
Review Panel
Microbiology
Submission Type
Contact ODE
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

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