Alpha-1-Antitrypsin, Antigen, Antiserum, Control

FDA product code DEM · 30 cleared devices

Class 2 Immunology

Regulation: 21 CFR 866.5130
Review panel: IM
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-08-11 – 2013-07-03

DEM 2013-07-03

HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS

Applicant The Binding Site Group , Ltd.

K number K123256

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DEM 2007-01-11

DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH

Applicant Dade Behring, Inc.

K number K063610

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DEM 2006-03-28

N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN

Applicant Dade Behring, Inc.

K number K053072

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DEM 2005-12-23

VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III

Applicant Ortho-Clinical Diagnostics, Inc.

K number K052819

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DEM 2005-05-13

QUANTIA A1-AT

Applicant Biokit, S.A.

K number K050596

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DEM 2003-09-04

ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY

Applicant Bayer Diagnostics Corp.

K number K031857

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DEM 2001-07-30

MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS

Applicant The Binding Site, Ltd.

K number K011663

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DEM 2001-05-18

TINA-QUANT ALPHA-1 ANTITRYPSIN

Applicant Rochdiag

K number K010978

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DEM 1999-11-24

K-ASSAY ALPHA-1 AT

Applicant Kamiya Biomedical Co.

K number K993444

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DEM 1998-01-09

TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY

Applicant Boehringer Mannheim Corp.

K number K972640

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DEM 1997-10-03

CHEMMATE LAMBDA

Applicant Ventana Medical Systems, Inc.

K number K973392

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DEM 1997-10-03

CHEMMATE KAPPA

Applicant Ventana Medical Systems, Inc.

K number K973391

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DEM 1997-10-03

CHEMMATE L26 (CD20)

Applicant Ventana Medical Systems, Inc.

K number K973390

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DEM 1997-10-03

CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING

Applicant Ventana Medical Systems, Inc.

K number K973389

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DEM 1997-07-14

N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT

Applicant Crestat Diagnostics, Inc.

K number K965100

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DEM 1997-04-25

IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)

Applicant Beckman Instruments, Inc.

K number K964766

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DEM 1994-03-30

VENTANA NEGATIVE CONTROL REAGENT

Applicant Ventana Medical Systems, Inc.

K number K931979

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DEM 1992-07-29

IL TEST ALPHA-1-ANTITRYPSIN (AAT)

Applicant Instrumentation Laboratory CO

K number K920005

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DEM 1991-12-09

ALPHA-1-ANTITRYPSIN IMMUNOLOGICAL NL TEST KIT

Applicant The Binding Site, Ltd.

K number K913666

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DEM 1989-02-17

SPQ(TM) ANTIBODY REAGENT SET II FOR AAT

Applicant Atlantic Antibodies

K number K890415

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DEM 1988-07-08

ALPHA1ANTITRYPSIN FOR TECHNICON DPA-1(TM) SYSTEM

Applicant Technicon Instruments Corp.

K number K882446

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DEM 1988-02-10

QM2/QM300 CONTROL B PACK

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

K number K875283

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DEM 1988-02-10

QM300 ALPHA1-ANTITRYPSIN ANTIBODY PACK

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

K number K875281

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DEM 1985-03-14

SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN

Applicant Applications Lab

K number K850587

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DEM 1980-09-16

J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO

Applicant J.T. Baker Chemical Co.

K number K801669

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DEM 1979-09-04

GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSIN

Applicant Protos Laboratories

K number K791605

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DEM 1978-08-21

RID SYSTEM-(ACP) TEST

Applicant Icl Scientific

K number K781408

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DEM 1978-02-03

RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT

Applicant Gelman Instrument Co.

K number K772080

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DEM 1976-11-16

LAS-R HUMAN ALPHA, ANTITRYPSIN TEST

Applicant Hyland Therapeutic Div., Travenol Laboratories

K number K760916

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DEM 1976-08-11

TEST, STREP, LATEX SLIDE

Applicant Gamma Biologicals, Inc.

K number K760034

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