MVJ · Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
Immunology · 21 CFR 866.5660 · Class 2
Overview
| Product Code | MVJ |
|---|---|
| Device Name | Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) |
| Regulation | 21 CFR 866.5660 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K071219 | ATHENA MULTI-LYTE GBM TEST SYSTEM | Zeus Scientific, Inc. | Dec 6, 2007 | SESE |
| K072358 | BIOPLEX VASCULITIS KIT | Bio-Rad Laboratories | Oct 31, 2007 | SESE |
| K011348 | PHASE II GBM IGG ANTIBODY EIA TEST | Scimedx Corp. | Jun 25, 2001 | SESE |
| K991890 | AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA | Cogent Diagnotics , Ltd. | Aug 9, 1999 | SESE |
| K984619 | BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT | The Binding Site, Ltd. | Feb 23, 1999 | SESE |
| K984336 | QUANTA LITE GBM ELISA | Inova Diagnostics, Inc. | Feb 8, 1999 | SESE |
Top Applicants
- Bio-Rad Laboratories — 1 clearance
- Cogent Diagnotics , Ltd. — 1 clearance
- Inova Diagnostics, Inc. — 1 clearance
- Scimedx Corp. — 1 clearance
- The Binding Site, Ltd. — 1 clearance
