Last synced on 6 December 2024 at 11:05 pm

Bartonella Spp. Serological Reagents

Page Type
Product Code
Definition
Tests or reagents used to detect IgG and/or IgM antibodies to Bartonella spp. in human serum or plasma. Used to aid in the diagnosis of either present or past infection with Bartonella spp. in patients suspected of exposure.
Physical State
Capture antigen substrates (e.g., slides, plates, strips), secondary reagents/conjugates, positive/negative controls, sample diluents, buffers, and media.
Technical Method
Target antibodies are captured by antigen preparations and detected with secondary reagents/conjugates.
Target Area
IgG and/or IgM antibodies to Bartonella spp.
Review Panel
Microbiology
Submission Type
Contact ODE
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 QIM is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Bartonella Spp. Serological Reagents

Page Type
Product Code
Definition
Tests or reagents used to detect IgG and/or IgM antibodies to Bartonella spp. in human serum or plasma. Used to aid in the diagnosis of either present or past infection with Bartonella spp. in patients suspected of exposure.
Physical State
Capture antigen substrates (e.g., slides, plates, strips), secondary reagents/conjugates, positive/negative controls, sample diluents, buffers, and media.
Technical Method
Target antibodies are captured by antigen preparations and detected with secondary reagents/conjugates.
Target Area
IgG and/or IgM antibodies to Bartonella spp.
Review Panel
Microbiology
Submission Type
Contact ODE
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 QIM is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.