| Device |
device to detect antibodies to hepatitis d virus |
| Definition |
The device to detect antibodies to hepatitis D Virus is an in vitro diagnostic device intended for prescription use for the detection of antibodies to the hepatitis D virus (anti-HDV) in human clinical specimens. The assay is intended as an aid in the diagnosis of HDV infection in individuals who are at risk for HDV infection. The assay is intended as an aid in diagnosis in conjunction with clinical findings and other diagnostic procedures. The assay is not intended for screening of blood, plasma, cells, or tissue donors. |
| Physical State |
A device consisting of chemiluminescence technology with magnetic microparticles as solid phase. The LIAISON XL Analyzer performs the complete sample processing (sample pre-dilutions, sample and reagent dispensing, incubations, wash processes) as well as the measurement and evaluation. |
| Technical Method |
chemiluminescence |
| Target Area |
Blood |
| Regulation Medical Specialty |
Immunology |
| Review Panel |
Microbiology |
|---|
| Product Code | SGW |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.3176
|
|---|
| 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 |
|
|
