Last synced on 6 December 2024 at 11:05 pm

Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples

Page Type
Product Code
Definition
A device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples is a device that consists of a container and reagents intended to stabilize microbial nucleic acids for the subsequent assessment of the relative abundance of microbial nucleic acids (i.e., microbiome) in human specimens by an assay validated for use with the device. The device may also be indicated for sample collection. The device is not intended for preserving morphology or viability of microorganisms.
Physical State
Liquid media.
Technical Method
Media stores and stabilizes microbial nucleic acids, and also preserves relative abundances of microorganisms.
Target Area
Human samples.
Regulation Medical Specialty
Microbiology
Review Panel
Microbiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
866.2952
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

Product code QPO is linked to regulation 21CFR866.2952, which does not seem to exist yet. It may be pending at the moment.

Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples

Page Type
Product Code
Definition
A device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples is a device that consists of a container and reagents intended to stabilize microbial nucleic acids for the subsequent assessment of the relative abundance of microbial nucleic acids (i.e., microbiome) in human specimens by an assay validated for use with the device. The device may also be indicated for sample collection. The device is not intended for preserving morphology or viability of microorganisms.
Physical State
Liquid media.
Technical Method
Media stores and stabilizes microbial nucleic acids, and also preserves relative abundances of microorganisms.
Target Area
Human samples.
Regulation Medical Specialty
Microbiology
Review Panel
Microbiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
866.2952
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

Product code QPO is linked to regulation 21CFR866.2952, which does not seem to exist yet. It may be pending at the moment.