PMA
P100017: ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV
FDA PMA · Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus · Abbott Molecular, Inc.
Key facts
| PMA number | P100017 |
|---|---|
| Trade name | ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV |
| Generic name | Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus |
| Applicant | Abbott Molecular, Inc. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | MZP |
| Approval date | May 17, 2011 |
| Docket number | 11M-0349 |
| Notice date | May 20, 2011 |
| 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- No Withdrawn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: