| Device |
variola virus nucleic acid-based detection assay |
| Definition |
The Variola virus nucleic acid-based detection assay is intended for individuals presenting with pustular or vesicular rash illness or other signs and symptoms of Variola virus infection. The test results must be used in conjunction with other diagnostic assays and clinical observations, as an aid to the diagnosis of infection, in accordance with the criteria defined by the appropriate public health authorities with the Federal government. |
| Physical State |
The Variola virus nucleic acid-based detection assays are in vitro diagnostic devices that consist of reagents and associated instrumentation for the detection and identification of Variola virus nucleic acids in human clinical specimens. |
| Technical Method |
Qualitative in vitro diagnostic assay that detects and identifies Variola virus nucleic acids in human clinical specimens. |
| Target Area |
In vitro diagnostic device |
| Regulation Medical Specialty |
Microbiology |
| Review Panel |
Microbiology |
|---|
| Product Code | PRA |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.3316
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
