NST · Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking
Immunology · 21 CFR 866.5660 · Class 2
Overview
| Product Code | NST |
|---|---|
| Device Name | Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking |
| 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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K091468 | IVD TECHNOLOGIES ACHRAB TEST KIT | Ivd Technologies | Nov 20, 2009 | SESE |
| K080523 | KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT | Kronus Market Development Associates, Inc. | Jun 17, 2008 | SESE |
| K051144 | ACETYLCHOLINE RECEPTOR AB (ARAB)RRA | Ibl-Hamburg GmbH | Nov 18, 2005 | SESE |
| K042248 | KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT | Kronus Market Development Associates, Inc. | Dec 17, 2004 | SESE |
Top Applicants
- Kronus Market Development Associates, Inc. — 2 clearances
- Ibl-Hamburg GmbH — 1 clearance
- Ivd Technologies — 1 clearance
