NTV · Myeloperoxidase, Immunoassay, System, Test
Immunology · 21 CFR 866.5600 · Class 2
Overview
| Product Code | NTV |
|---|---|
| Device Name | Myeloperoxidase, Immunoassay, System, Test |
| Regulation | 21 CFR 866.5600 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K071474 | DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426 | Siemens Healthcare Diagnostics | Dec 10, 2008 | SESE |
| K050029 | CARDIOMPO TEST | Prognostix, Inc. | May 10, 2005 | SESE |
Top Applicants
- Siemens Healthcare Diagnostics — 1 clearance
- Prognostix, Inc. — 1 clearance
