Device |
bacteriophage and controls, b. anthracis lysis |
Regulation Description |
In vitro diagnostic device for Bacillus spp. detection. |
Definition |
A gamma phage lysis assay intended for the identification of bacillus anthracis from non-hemolytic, aerobic gram positive colonies isolated from sheep blood agar. To aid in the laboratory identification of bacillus anthracis culture growth by lysis with a specific bacteriophage. |
Physical State |
Cultured isolates |
Technical Method |
Bacteriophage, culture |
Target Area |
Systemic |
Regulation Medical Specialty |
Microbiology |
Review Panel |
Microbiology |
Product Code | NVQ |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
Submission Type |
510(k)
|
Regulation Number |
866.3045
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|