JZG · System, Test, Beta-2-Microglobulin Immunological
Immunology · 21 CFR 866.5630 · Class 2
Overview
| Product Code | JZG |
|---|---|
| Device Name | System, Test, Beta-2-Microglobulin Immunological |
| Regulation | 21 CFR 866.5630 |
| Device Class | Class 2 |
| Review Panel | Immunology |
Identification
A beta-2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques beta-2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement of beta-2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Recent Cleared Devices (20 of 53)
Showing 20 most recent of 53 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K161297 | Beta-2-Microglobulin | Beckman Coulter Ireland, Inc. | Jun 7, 2016 | SESE |
| K122066 | HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS | The Binding Site Group , Ltd. | Aug 30, 2012 | SESE |
| K110874 | ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR | Siemens Healthcare Diagnostics, Inc. | Jan 20, 2012 | SESE |
| K083289 | HUMAN BETA-2 MICROGLOBULIN KIT | The Binding Site, Ltd. | May 6, 2009 | SESE |
| K083463 | DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M | Siemens Healthcare Diagnostics | Mar 13, 2009 | SESE |
| K072078 | QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307 | Biokit, S.A. | Dec 19, 2007 | SESE |
| K063272 | DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH | Dade Behring, Inc. | Jan 26, 2007 | SESE |
| K050613 | QUANTIA BETA-2 MICROGLOBULIN | Biokit, S.A. | Aug 16, 2005 | SESE |
| K032692 | DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 | Dako A/S | Jan 22, 2004 | SESE |
| K014270 | MININEPH HUMAN B2-MICROGLOBULIN KIT | The Binding Site, Ltd. | Aug 15, 2002 | SESE |
| K002731 | N LATEX B2-MICROGLOBULIN | Dade Behring, Inc. | Nov 20, 2000 | SESE |
| K001022 | BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 | Biocheck, Inc. | Sep 26, 2000 | SESE |
| K993711 | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS) | Bayer Corp. | Dec 16, 1999 | SESE |
| K991136 | B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM | Olympus America, Inc. | May 11, 1999 | SESE |
| K983895 | IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT | Beckman Coulter, Inc. | Nov 25, 1998 | SESE |
| K980724 | TINAQUANT B 2-MICROGLOBULIN ASSAY | Boehringer Mannheim Corp. | Oct 16, 1998 | SESE |
| K973813 | IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT | Beckman Instruments, Inc. | Nov 20, 1997 | SESE |
| K964791 | B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | Bayer Corp. | May 29, 1997 | SESE |
| K964767 | QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA( | R&D Systems, Inc. | May 29, 1997 | SESE |
| K955596 | N LATEX B2-MICROGLOBULIN REAGENT | Behring Diagnostics, Inc. | Oct 3, 1996 | SESE |
Top Applicants
- The Binding Site, Ltd. — 6 clearances
- Pharmacia, Inc. — 5 clearances
- Diagnostic Systems Laboratories, Inc. — 3 clearances
- Diagnostic Products Corp. — 3 clearances
- Behring Diagnostics, Inc. — 3 clearances
