System, Test, Beta-2-Microglobulin Immunological

FDA product code JZG · 53 cleared devices

Class 2 Immunology

Regulation: 21 CFR 866.5630
Review panel: IM
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1984-04-20 – 2016-06-07

JZG 2016-06-07

Beta-2-Microglobulin

Applicant Beckman Coulter Ireland, Inc.

K number K161297

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JZG 2012-08-30

HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS

Applicant The Binding Site Group , Ltd.

K number K122066

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JZG 2012-01-20

ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR

Applicant Siemens Healthcare Diagnostics, Inc.

K number K110874

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JZG 2009-05-06

HUMAN BETA-2 MICROGLOBULIN KIT

Applicant The Binding Site, Ltd.

K number K083289

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JZG 2009-03-13

DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M

Applicant Siemens Healthcare Diagnostics

K number K083463

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JZG 2007-12-19

QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307

Applicant Biokit, S.A.

K number K072078

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JZG 2007-01-26

DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH

Applicant Dade Behring, Inc.

K number K063272

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JZG 2005-08-16

QUANTIA BETA-2 MICROGLOBULIN

Applicant Biokit, S.A.

K number K050613

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JZG 2004-01-22

DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368

Applicant Dako A/S

K number K032692

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JZG 2002-08-15

MININEPH HUMAN B2-MICROGLOBULIN KIT

Applicant The Binding Site, Ltd.

K number K014270

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JZG 2000-11-20

N LATEX B2-MICROGLOBULIN

Applicant Dade Behring, Inc.

K number K002731

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JZG 2000-09-26

BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061

Applicant Biocheck, Inc.

K number K001022

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JZG 1999-12-16

ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS)

Applicant Bayer Corp.

K number K993711

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JZG 1999-05-11

B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM

Applicant Olympus America, Inc.

K number K991136

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JZG 1998-11-25

IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT

Applicant Beckman Coulter, Inc.

K number K983895

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JZG 1998-10-16

TINAQUANT B 2-MICROGLOBULIN ASSAY

Applicant Boehringer Mannheim Corp.

K number K980724

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JZG 1997-11-20

IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT

Applicant Beckman Instruments, Inc.

K number K973813

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JZG 1997-05-29

B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)

Applicant Bayer Corp.

K number K964791

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JZG 1997-05-29

QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA(

Applicant R&D Systems, Inc.

K number K964767

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JZG 1996-10-03

N LATEX B2-MICROGLOBULIN REAGENT

Applicant Behring Diagnostics, Inc.

K number K955596

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JZG 1996-01-30

HUMAN BETA-2 MICROGLOBULIN TURBINDIMETRIC KIT

Applicant The Binding Site, Ltd.

K number K946070

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JZG 1996-01-30

HUMAN BETA-2 MICROGLOBULIN ENHANCED NEPHELOMETRIC KIT

Applicant The Binding Site, Ltd.

K number K946069

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JZG 1996-01-30

HUMAN BETA-2 MICROGLOBULIN ENHANCED RADIAL IMMUNODIFFUSION KIT

Applicant The Binding Site, Ltd.

K number K946068

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JZG 1995-06-20

AURAFLEX B2-MICROGLOBULIN

Applicant Organon Teknika Corp.

K number K944846

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JZG 1995-05-15

IL TEST BETA-2MICROGLOBULIN

Applicant Instrumentation Laboratory CO

K number K943686

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JZG 1995-02-10

LIQUISPEX(TM) LIQUID B2M CONTROL LEVEL 1 AND 2

Applicant Clinical Controls, Inc.

K number K946048

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JZG 1994-04-21

BECKMAN BETA-2-MICROGLOBULIN (B2M)

Applicant Beckman Instruments, Inc.

K number K940353

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JZG 1993-09-24

ADDED USE CLAIM FOR DUPONT ACA BETA-2-MICROGLOBULIN TEST PACK

Applicant Dupont Medical Products

K number K933648

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JZG 1993-09-24

IMMULITE BETA-2-MICROGLOBULIN

Applicant Diagnostic Products Corp.

K number K931702

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JZG 1992-09-23

COULTER BETA-2 MICROGLOBULIN IMMUNOASSAY

Applicant Coulter Corp.

K number K923421

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JZG 1992-05-28

SYN ELISA BETA 2 MICROGLOBULIN TEST KIT

Applicant Elias U.S.A., Inc.

K number K920132

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JZG 1992-03-17

B2-MICROGLOBULIN RADIOIMMUNOASSAY

Applicant Nichols Institute

K number K920300

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JZG 1992-03-17

DSL ACTIVE BETA2-MICROGLOBULIN (DSL 6500)

Applicant Diagnostic Systems Laboratories, Inc.

K number K915508

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JZG 1991-11-22

ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K914225

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JZG 1991-11-07

HUMAN BETA-2 MICROGLOBIN EN-RID KIT

Applicant The Binding Site, Ltd.

K number K913131

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JZG 1991-09-10

DSL BETA 2 MICROGLOBULIN (DSL 6200)

Applicant Diagnostic Systems Laboratories, Inc.

K number K911881

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JZG 1991-08-13

DSL BETA 2 MICROGLOBULIN (DSL 6100)

Applicant Diagnostic Systems Laboratories, Inc.

K number K912173

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JZG 1991-07-24

COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA

Applicant Diagnostic Products Corp.

K number K912940

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JZG 1991-04-05

NA ALPHA 1 MICROGLOBULIN KIT

Applicant Behring Diagnostics, Inc.

K number K904254

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JZG 1991-03-06

MILENIA BETA-2 MICROGLOBULIN

Applicant Diagnostic Products Corp.

K number K910052

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JZG 1990-09-25

LABMASTER BETA-2-MICROGLOBULIN ELISA TEST KIT TM

Applicant Bioproducts For Science, Inc.

K number K903215

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JZG 1990-08-17

PHARMACIA DELFIA SYSTEM B2-MICRO

Applicant Pharmacia, Inc.

K number K903578

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JZG 1990-04-02

BETA-2 MICROGLOBULIN EIA

Applicant Serex, Inc.

K number K901333

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JZG 1990-02-26

AIA-PACK BMG

Applicant Tosoh Medics, Inc.

K number K900440

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JZG 1990-02-05

PHARMACIA B2 MICRO EIA

Applicant Pharmacia, Inc.

K number K900449

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JZG 1989-10-17

BETA2 M-TRAC BY ENZYME BEAD-BASED IMMUNOASSAY EIA

Applicant Incstar Corp.

K number K895496

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JZG 1989-03-16

BETA-2 MICROGLOBULIN EIA

Applicant Serex, Inc.

K number K890694

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JZG 1989-03-09

IMX B2-MICROGLOBULIN

Applicant Abbott Laboratories

K number K890421

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JZG 1988-04-21

PHARMACIA B2-MICRO RIA

Applicant Pharmacia, Inc.

K number K880719

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JZG 1986-11-12

ABBOTT B2-MICROGLOBULIN RIA

Applicant Abbott Laboratories

K number K864130

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JZG 1985-02-14

PHARMACIA B2-MICRO EIA

Applicant Pharmacia, Inc.

K number K844469

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JZG 1984-12-03

ENZYGNOST BETA-2 MICROGLOBULIN TEST

Applicant Behring Diagnostics, Inc.

K number K843967

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JZG 1984-04-20

B2-MICRO CONTROL

Applicant Pharmacia, Inc.

K number K840601

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