Last synced on 30 November 2024 at 11:09 am

Anaplasma Spp. And Ehrlichia Spp. Serological Reagents

Page Type
Product Code
Definition
Tests or reagents used to detect IgG and/or IgM antibodies to Anaplasma spp. and/or Ehrlichia spp. in human serum or plasma. Used to aid in the diagnosis of either present or past infection with Anaplasma spp. and/or Ehrlichia 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 Anaplasma spp. and/or Ehrlichia 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 QIO is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Anaplasma Spp. And Ehrlichia Spp. Serological Reagents

Page Type
Product Code
Definition
Tests or reagents used to detect IgG and/or IgM antibodies to Anaplasma spp. and/or Ehrlichia spp. in human serum or plasma. Used to aid in the diagnosis of either present or past infection with Anaplasma spp. and/or Ehrlichia 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 Anaplasma spp. and/or Ehrlichia 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 QIO is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.