Complement C3, Antigen, Antiserum, Control

FDA product code CZW · 44 cleared devices

Class 2 Immunology

Regulation: 21 CFR 866.5240
Review panel: IM
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-07-20 – 2010-08-13

CZW 2010-08-13

SPAPLUS

Applicant The Binding Site Group , Ltd.

K number K100179

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CZW 2007-03-19

COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL

Applicant Thermo Electron OY

K number K063150

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CZW 2006-09-22

DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH

Applicant Dade Behring, Inc.

K number K061852

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CZW 2005-05-02

N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)

Applicant Dade Behring, Inc.

K number K050665

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CZW 2004-10-19

VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III

Applicant Ortho-Clinical Diagnostics

K number K042494

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CZW 2004-01-13

IBL C3D-CIC EIA TEST

Applicant Ibl GmbH

K number K032796

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CZW 2003-08-07

SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI

Applicant Beckman Coulter, Inc.

K number K032035

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CZW 2001-11-29

TINA-QUANT COMPLEMENT C3C TEST SYSTEM

Applicant Roche Diagnostics Corp.

K number K012361

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CZW 2001-06-25

WAKO AUTOKIT C3

Applicant Wako Chemicals USA, Inc.

K number K010326

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CZW 2000-03-27

RANDOX COMPLEMENT C3

Applicant Randox Laboratories, Ltd.

K number K000469

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CZW 2000-03-01

DIMENSION C3 FLEX REAGENT CARTRIDGE

Applicant Dade Behring, Inc.

K number K994296

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CZW 1999-12-20

C3 MININEPH ANTISERUM

Applicant The Binding Site, Ltd.

K number K981783

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CZW 1999-11-24

K-ASSAY C3

Applicant Kamiya Biomedical Co.

K number K993437

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CZW 1999-11-09

ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM

Applicant Bayer Corp.

K number K991907

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CZW 1998-11-04

C3

Applicant Abbott Laboratories

K number K983441

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CZW 1997-07-14

N-ASSAY TIA MULTI V-NL

Applicant Crestat Diagnostics, Inc.

K number K964298

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CZW 1997-06-11

IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT

Applicant Beckman Instruments, Inc.

K number K964842

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CZW 1996-10-18

OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT

Applicant Olympus America, Inc.

K number K962409

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CZW 1996-09-25

QUANTEX C3

Applicant Instrumentation Laboratory CO

K number K962199

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CZW 1996-02-21

N PROTEIN STANDARS SY

Applicant Behring Diagnostics, Inc.

K number K955857

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CZW 1995-07-17

N PROTEIN STANDARD SY

Applicant Behring Diagnostics, Inc.

K number K952594

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CZW 1992-06-16

IL TEST COMPLEMENT 3

Applicant Instrumentation Laboratory CO

K number K920007

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CZW 1991-05-09

RAICHEM SPIA C3 REAGENT

Applicant Reagents Applications, Inc.

K number K911900

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CZW 1990-09-07

C3C AND C4 RID KITS

Applicant The Binding Site, Ltd.

K number K902382

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CZW 1989-04-14

EZ COMPLEMENT C3

Applicant Diamedix Corp.

K number K892127

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CZW 1989-04-14

EZ COMPLEMENT C2

Applicant Diamedix Corp.

K number K892125

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CZW 1989-03-06

THE TURBOX ANALYSER SYSTEM COMPLEMENT C3 AND C4

Applicant Unipath , Ltd.

K number K890675

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CZW 1987-06-12

QM300 C3 ANTIBODY PACK

Applicant Kallestad Diag, A Div. of Erbamont, Inc.

K number K871939

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CZW 1987-05-15

PRECIMAT(R) C3

Applicant Boehringer Mannheim Corp.

K number K871024

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CZW 1987-04-21

DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY

Applicant Dako Corp.

K number K871346

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CZW 1986-06-06

IMMUNOMEDICS SERUM ELISA TEST SYSTEM

Applicant Immunomedics, Inc.

K number K861362

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CZW 1985-09-16

GILFORD C3 COMPLEMENT REAGENT

Applicant Gilford

K number K853466

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CZW 1985-06-05

RADIAL IMMUNODIFFUSION PLATES C3 & C4

Applicant Cooper Biomedical, Inc.

K number K851286

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CZW 1985-03-05

SPQ TEST SYSTEM FOR COMPLEMENT C3

Applicant Applications Lab

K number K850588

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CZW 1984-01-24

C3 ANTISERUM CONTROL

Applicant Technicon Instruments Corp.

K number K834604

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CZW 1983-07-18

RABBITT ANTISERUM TO HUMAN C3C

Applicant Dako Corp.

K number K831905

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CZW 1983-04-05

FIAX COMPLEMENT C3 TEST KIT

Applicant Intl. Diagnostic Technology

K number K830668

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CZW 1981-09-23

IMMUNOGL. FRCT. OF RABBIT ANTISER.-C3

Applicant Dako Corp.

K number K812491

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CZW 1981-04-08

SCRIPPSYSTEM C3 RID KIT

Applicant Scripps-Miles, Inc.

K number K810501

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CZW 1980-06-30

COMPLEMENT C3 NEPHELOMETRIC ASSAY

Applicant J.T. Baker Chemical Co.

K number K801363

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CZW 1980-02-19

COMPLEMENT C3 REAGENT SYSTEM

Applicant Calbiochem-Behring Corp.

K number K800212

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CZW 1979-10-17

LANCER L-INA ANTI-C3

Applicant Sherwood Medical Co.

K number K791404

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CZW 1978-11-08

NEPHELRATE ANTISERUMS C3C

Applicant Antibodies, Inc.

K number K781653

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CZW 1976-07-20

SERUM, B1A GLOBULIN C3C GOAT ANTI-HUMAN

Applicant Oxford Laboratories, Inc.

K number K760148

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