Hepatitis Viral B Dna Detection
Device Code: 3602
Product Code(s):
MKT Definition: Nucleic Acid Assay For Detection Of Hepatitis B Virus (HBV) DNA Is An In Vitro Nucleic Acid Assay For Detection And Quantitation Of HBV DNA In Human Serum Or Plasma. The Assay Can Be Used To Measure HBV DNA Levels At Baseline And During Treatment To
Device Classification Information
| Device Type ID | 3602 |
| Device Name | Hepatitis Viral B Dna Detection |
| Review Panel | Microbiology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MKT |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3602 |
| Device | Hepatitis Viral B Dna Detection |
| Product Code | MKT |
| FDA Device Classification | Class 3 Medical Device |
| Recalls |
|---|
| Manufacturer | Recall Class | Date Posted |
| 1 | Roche Diagnostics Operations, Inc. | II | Oct-25-2016 |
TPLC Last Update: 2019-04-02 20:33:02