Product code JZG
- Device name
- System, Test, Beta-2-Microglobulin Immunological
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5630
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K161297 | Beta-2-Microglobulin | Beckman Coulter Ireland, Inc. | 2016-06-07 |
| K122066 | HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS | The Binding Site Group , Ltd. | 2012-08-30 |
| K110874 | ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR | Siemens Healthcare Diagnostics, Inc. | 2012-01-20 |
| K083289 | HUMAN BETA-2 MICROGLOBULIN KIT | The Binding Site, Ltd. | 2009-05-06 |
| K083463 | DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M | Siemens Healthcare Diagnostics | 2009-03-13 |
| K072078 | QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307 | Biokit, S.A. | 2007-12-19 |
| K063272 | DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH | Dade Behring, Inc. | 2007-01-26 |
| K050613 | QUANTIA BETA-2 MICROGLOBULIN | Biokit, S.A. | 2005-08-16 |
| K032692 | DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 | Dako A/S | 2004-01-22 |
| K014270 | MININEPH HUMAN B2-MICROGLOBULIN KIT | The Binding Site, Ltd. | 2002-08-15 |
| K002731 | N LATEX B2-MICROGLOBULIN | Dade Behring, Inc. | 2000-11-20 |
| K001022 | BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 | Biocheck, Inc. | 2000-09-26 |
| K993711 | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS) | Bayer Corp. | 1999-12-16 |
| K991136 | B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM | Olympus America, Inc. | 1999-05-11 |
| K983895 | IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT | Beckman Coulter, Inc. | 1998-11-25 |
| K980724 | TINAQUANT B 2-MICROGLOBULIN ASSAY | Boehringer Mannheim Corp. | 1998-10-16 |
| K973813 | IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT | Beckman Instruments, Inc. | 1997-11-20 |
| K964791 | B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | Bayer Corp. | 1997-05-29 |
| K964767 | QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA( | R&D Systems, Inc. | 1997-05-29 |
| K955596 | N LATEX B2-MICROGLOBULIN REAGENT | Behring Diagnostics, Inc. | 1996-10-03 |
| K946069 | HUMAN BETA-2 MICROGLOBULIN ENHANCED NEPHELOMETRIC KIT | The Binding Site, Ltd. | 1996-01-30 |
| K946068 | HUMAN BETA-2 MICROGLOBULIN ENHANCED RADIAL IMMUNODIFFUSION KIT | The Binding Site, Ltd. | 1996-01-30 |
| K946070 | HUMAN BETA-2 MICROGLOBULIN TURBINDIMETRIC KIT | The Binding Site, Ltd. | 1996-01-30 |
| K944846 | AURAFLEX B2-MICROGLOBULIN | Organon Teknika Corp. | 1995-06-20 |
| K943686 | IL TEST BETA-2MICROGLOBULIN | Instrumentation Laboratory CO | 1995-05-15 |
| K946048 | LIQUISPEX(TM) LIQUID B2M CONTROL LEVEL 1 AND 2 | Clinical Controls, Inc. | 1995-02-10 |
| K940353 | BECKMAN BETA-2-MICROGLOBULIN (B2M) | Beckman Instruments, Inc. | 1994-04-21 |
| K933648 | ADDED USE CLAIM FOR DUPONT ACA BETA-2-MICROGLOBULIN TEST PACK | Dupont Medical Products | 1993-09-24 |
| K931702 | IMMULITE BETA-2-MICROGLOBULIN | Diagnostic Products Corp. | 1993-09-24 |
| K923421 | COULTER BETA-2 MICROGLOBULIN IMMUNOASSAY | Coulter Corp. | 1992-09-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04048474017892 | Beta-2 Microglobulin ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-26 |
| 06971674868460 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 06971674868019 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 06971674866619 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 06971674866534 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 06971674866541 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 06971674866558 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 06971674866565 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 06971674866572 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 06971674866589 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 06971674866596 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 06971674866602 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 07613336133583 | Tinaquant ß2Microglobulin | Roche Diagnostics GmbH | 2020-03-05 |
| 00380740156312 | ARCHITECT | ABBOTT LABORATORIES | 2020-03-03 |
| 00380740156268 | ARCHITECT | ABBOTT LABORATORIES | 2020-03-03 |
| 00850392007619 | BioCheck Beta-2 Microglobulin EIA Test Kit | BIOCHECK, INC. | 2019-10-08 |
| 00840239017895 | Beta-2 Microglobulin ELISA | DRG International Inc | 2019-06-10 |
| 05055273208276 | B2Microglobulin (B2M) | RANDOX LABORATORIES LIMITED | 2019-06-03 |
| 05055273200775 | B2Microglobulin (B2M) | RANDOX LABORATORIES LIMITED | 2019-06-03 |
| B24225BMGHUE010 | Beta-2 Microglobulin ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. | 2017-08-03 |
| 04560189211179 | AIA-PACK BMG Sample Diluting Solution | TOSOH CORPORATION | 2016-09-24 |
| 04560189211186 | AIA-PACK BMG Calibrator Set | TOSOH CORPORATION | 2016-09-24 |
| 05051700005746 | Human Beta-2 Microglobulin NANORID Radial Immunodiffusion Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700006514 | Human Beta-2 Microglobulin Latex Kit for use on the Siemens BN™II | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 15099590010485 | AU | Beckman Coulter, Inc. | 2016-09-24 |
| 14560189210261 | ST AIA-PACK BMG | TOSOH CORPORATION | 2016-09-24 |
| 04015630928781 | Tinaquant 2Microglobulin | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630900152 | Tinaquant 2Microglobulin | Roche Diagnostics GmbH | 2016-09-20 |
| 00380740054199 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740030063 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |