Last synced on 6 December 2024 at 11:05 pm

Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens

Page Type
Product Code
Definition
A Coccidioides spp. nucleic acid detection system for respiratory specimens is a qualitative test for the detection of Coccidioides spp. nucleic acids directly in clinical respiratory specimens from patients with signs and symptoms of coccidioidomycosis and suspicion of infection.
Physical State
In vitro diagnostic devices that consist of reagents and associated instrumentation for the detection and identification of Coccidioides spp. nucleic acids in respiratory specimens.
Technical Method
Qualitative in vitro diagnostic assay that detects and identifies Coccidioides spp. nucleic acids in respiratory specimens.
Target Area
Respiratory clinical specimens from patients suspected of coccidioidomycosis
Regulation Medical Specialty
Microbiology
Review Panel
Microbiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
866.3376
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 QAA is linked to regulation 21CFR866.3376, which does not seem to exist yet. It may be pending at the moment.

Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens

Page Type
Product Code
Definition
A Coccidioides spp. nucleic acid detection system for respiratory specimens is a qualitative test for the detection of Coccidioides spp. nucleic acids directly in clinical respiratory specimens from patients with signs and symptoms of coccidioidomycosis and suspicion of infection.
Physical State
In vitro diagnostic devices that consist of reagents and associated instrumentation for the detection and identification of Coccidioides spp. nucleic acids in respiratory specimens.
Technical Method
Qualitative in vitro diagnostic assay that detects and identifies Coccidioides spp. nucleic acids in respiratory specimens.
Target Area
Respiratory clinical specimens from patients suspected of coccidioidomycosis
Regulation Medical Specialty
Microbiology
Review Panel
Microbiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
866.3376
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 QAA is linked to regulation 21CFR866.3376, which does not seem to exist yet. It may be pending at the moment.