Atlas FDA

JZG

53 FDA 510(k) clearances · Product code

86 daysmedian time to decision
290 days90th percentile
53clearances measured

FDA profile

Official device name
System, Test, Beta-2-Microglobulin Immunological
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5630
Medical specialty
Immunology
Adverse events (MAUDE)
2015: 50
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Beta-2-Microglobulin (K161297)Beckman Coulter Ireland, Inc.2016-06-07
HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS (K122066)The Binding Site Group , Ltd.2012-08-30
ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR (K110874)Siemens Healthcare Diagnostics, Inc.2012-01-20
HUMAN BETA-2 MICROGLOBULIN KIT (K083289)The Binding Site, Ltd.2009-05-06
DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M (K083463)Siemens Healthcare Diagnostics2009-03-13
QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307 (K072078)Biokit, S.A.2007-12-19
DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH (K063272)Dade Behring, Inc.2007-01-26
QUANTIA BETA-2 MICROGLOBULIN (K050613)Biokit, S.A.2005-08-16
DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 (K032692)Dako A/S2004-01-22
MININEPH HUMAN B2-MICROGLOBULIN KIT (K014270)The Binding Site, Ltd.2002-08-15
N LATEX B2-MICROGLOBULIN (K002731)Dade Behring, Inc.2000-11-20
BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 (K001022)Biocheck, Inc.2000-09-26
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS) (K993711)Bayer Corp.1999-12-16
B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM (K991136)Olympus America, Inc.1999-05-11
IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT (K983895)Beckman Coulter, Inc.1998-11-25
TINAQUANT B 2-MICROGLOBULIN ASSAY (K980724)Boehringer Mannheim Corp.1998-10-16
IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT (K973813)Beckman Instruments, Inc.1997-11-20
QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA( (K964767)R&D Systems, Inc.1997-05-29
B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K964791)Bayer Corp.1997-05-29
N LATEX B2-MICROGLOBULIN REAGENT (K955596)Behring Diagnostics, Inc.1996-10-03
HUMAN BETA-2 MICROGLOBULIN ENHANCED NEPHELOMETRIC KIT (K946069)The Binding Site, Ltd.1996-01-30
HUMAN BETA-2 MICROGLOBULIN TURBINDIMETRIC KIT (K946070)The Binding Site, Ltd.1996-01-30
HUMAN BETA-2 MICROGLOBULIN ENHANCED RADIAL IMMUNODIFFUSION KIT (K946068)The Binding Site, Ltd.1996-01-30
AURAFLEX B2-MICROGLOBULIN (K944846)Organon Teknika Corp.1995-06-20
IL TEST BETA-2MICROGLOBULIN (K943686)Instrumentation Laboratory CO1995-05-15
LIQUISPEX(TM) LIQUID B2M CONTROL LEVEL 1 AND 2 (K946048)Clinical Controls, Inc.1995-02-10
BECKMAN BETA-2-MICROGLOBULIN (B2M) (K940353)Beckman Instruments, Inc.1994-04-21
IMMULITE BETA-2-MICROGLOBULIN (K931702)Diagnostic Products Corp.1993-09-24
ADDED USE CLAIM FOR DUPONT ACA BETA-2-MICROGLOBULIN TEST PACK (K933648)Dupont Medical Products1993-09-24
COULTER BETA-2 MICROGLOBULIN IMMUNOASSAY (K923421)Coulter Corp.1992-09-23
SYN ELISA BETA 2 MICROGLOBULIN TEST KIT (K920132)Elias U.S.A., Inc.1992-05-28
DSL ACTIVE BETA2-MICROGLOBULIN (DSL 6500) (K915508)Diagnostic Systems Laboratories, Inc.1992-03-17
B2-MICROGLOBULIN RADIOIMMUNOASSAY (K920300)Nichols Institute1992-03-17
ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR (K914225)E.I. Dupont DE Nemours & Co., Inc.1991-11-22
HUMAN BETA-2 MICROGLOBIN EN-RID KIT (K913131)The Binding Site, Ltd.1991-11-07
DSL BETA 2 MICROGLOBULIN (DSL 6200) (K911881)Diagnostic Systems Laboratories, Inc.1991-09-10
DSL BETA 2 MICROGLOBULIN (DSL 6100) (K912173)Diagnostic Systems Laboratories, Inc.1991-08-13
COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA (K912940)Diagnostic Products Corp.1991-07-24
NA ALPHA 1 MICROGLOBULIN KIT (K904254)Behring Diagnostics, Inc.1991-04-05
MILENIA BETA-2 MICROGLOBULIN (K910052)Diagnostic Products Corp.1991-03-06
LABMASTER BETA-2-MICROGLOBULIN ELISA TEST KIT TM (K903215)Bioproducts For Science, Inc.1990-09-25
PHARMACIA DELFIA SYSTEM B2-MICRO (K903578)Pharmacia, Inc.1990-08-17
BETA-2 MICROGLOBULIN EIA (K901333)Serex, Inc.1990-04-02
AIA-PACK BMG (K900440)Tosoh Medics, Inc.1990-02-26
PHARMACIA B2 MICRO EIA (K900449)Pharmacia, Inc.1990-02-05
BETA2 M-TRAC BY ENZYME BEAD-BASED IMMUNOASSAY EIA (K895496)Incstar Corp.1989-10-17
BETA-2 MICROGLOBULIN EIA (K890694)Serex, Inc.1989-03-16
IMX B2-MICROGLOBULIN (K890421)Abbott Laboratories1989-03-09
PHARMACIA B2-MICRO RIA (K880719)Pharmacia, Inc.1988-04-21
ABBOTT B2-MICROGLOBULIN RIA (K864130)Abbott Laboratories1986-11-12
PHARMACIA B2-MICRO EIA (K844469)Pharmacia, Inc.1985-02-14
ENZYGNOST BETA-2 MICROGLOBULIN TEST (K843967)Behring Diagnostics, Inc.1984-12-03
B2-MICRO CONTROL (K840601)Pharmacia, Inc.1984-04-20

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Every clearance here is in the API, with alerts when new ones post.