Last synced on 30 November 2024 at 11:09 am

Multiple Osteoarticular Pathogen Antigen Kit

Page Type
Product Code
Definition
Qualitative detection of microbial antigen in synovial fluid
Physical State
Reaction of the microbial antigen present in the sample with a genera-specific anti-microbial polyclonal antibody
Technical Method
Immunometric multiplexed assay run on a fluorescent immunoassay instrument
Target Area
Synovial fluid
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 QHV is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Multiple Osteoarticular Pathogen Antigen Kit

Page Type
Product Code
Definition
Qualitative detection of microbial antigen in synovial fluid
Physical State
Reaction of the microbial antigen present in the sample with a genera-specific anti-microbial polyclonal antibody
Technical Method
Immunometric multiplexed assay run on a fluorescent immunoassay instrument
Target Area
Synovial fluid
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 QHV is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.