PMA
P120012: ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)
FDA PMA · Assay, genotyping, hepatitis c virus · Abbott Molecular
Key facts
| PMA number | P120012 |
|---|---|
| Trade name | ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG) |
| Generic name | Assay, genotyping, hepatitis c virus |
| Applicant | Abbott Molecular |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | OBF |
| Approval date | Jun 20, 2013 |
| Docket number | 13M-0758 |
| Notice date | Jun 24, 2013 |
| Establishment registration | 3005248192 |
| FEI number | 3005248192 |
At a glance
- 10–99 Supplements
- Mar 5, 2021 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: