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Rickettsia Spp. Nucleic Acid Based Detection Assay

Page Type
Product Code
Definition
An in vitro diagnostic test for the detection of Rickettsia spp. nucleic acids in specimens from individuals with signs or symptoms of rickettsial infection and epidemiological risk factors consistent with potential exposure. Test results are used in conjunction with other diagnostic assays and clinical observations to aid in the diagnosis infection, in accordance with criteria defined by the appropriate public health authorities in the Federal government.
Physical State
In vitro diagnostic devices that consist of reagents and associated instrumentation for the detection and identification of Rickettsia spp. nucleic acids in human clinical specimens.
Technical Method
Qualitative in vitro diagnostic assay that detects and identifies Rickettsia spp. nucleic acids in human clinical specimens.
Target Area
Clinical specimens from patients suspected of infection with Rickettsia spp.
Regulation Medical Specialty
Microbiology
Review Panel
Microbiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
866.3316
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

Product code PVQ is linked to regulation 21CFR866.3316, which does not seem to exist yet. It may be pending at the moment.

Rickettsia Spp. Nucleic Acid Based Detection Assay

Page Type
Product Code
Definition
An in vitro diagnostic test for the detection of Rickettsia spp. nucleic acids in specimens from individuals with signs or symptoms of rickettsial infection and epidemiological risk factors consistent with potential exposure. Test results are used in conjunction with other diagnostic assays and clinical observations to aid in the diagnosis infection, in accordance with criteria defined by the appropriate public health authorities in the Federal government.
Physical State
In vitro diagnostic devices that consist of reagents and associated instrumentation for the detection and identification of Rickettsia spp. nucleic acids in human clinical specimens.
Technical Method
Qualitative in vitro diagnostic assay that detects and identifies Rickettsia spp. nucleic acids in human clinical specimens.
Target Area
Clinical specimens from patients suspected of infection with Rickettsia spp.
Regulation Medical Specialty
Microbiology
Review Panel
Microbiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
866.3316
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

Product code PVQ is linked to regulation 21CFR866.3316, which does not seem to exist yet. It may be pending at the moment.