PMA
BP060002: Abbott RealTime HIV-1 Amplification Reagent Kit; Abbott RealTime HIV-1 Calibrator Kit; Abbott RealTime HIV-1 Control Kit
FDA PMA · Human immunodeficiency virus (hiv) viral load monitoring test · Abbott Molecular
Key facts
| PMA number | BP060002 |
|---|---|
| Trade name | Abbott RealTime HIV-1 Amplification Reagent Kit; Abbott RealTime HIV-1 Calibrator Kit; Abbott RealTime HIV-1 Control Kit |
| Generic name | Human immunodeficiency virus (hiv) viral load monitoring test |
| Applicant | Abbott Molecular |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | QUM |
| Approval date | May 11, 2007 |
| Establishment registration | 3005248192 |
| FEI number | 3005248192 |
At a glance
- 10–99 Supplements
- Mar 9, 2022 Latest supplement decision
- No Withdrawn
- No 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: