Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control

FDA product code LRM · 29 cleared devices

Class 2 Immunology

Regulation: 21 CFR 866.5100
Review panel: IM
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1987-05-14 – 2010-12-09

LRM 2010-12-09

IMMULISA DSDNA ANTIBODY ELISA

Applicant Immco Diagnostics, Inc.

K number K101319

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LRM 2009-04-15

EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)

Applicant Euroimmun Us, Inc.

K number K083381

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LRM 2006-11-21

FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT

Applicant The Binding Site, Ltd.

K number K062183

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LRM 2004-05-13

VARELISA SSDNA ANTIBODIES, MODEL 14896

Applicant Pharmacia Deutschland GmbH

K number K040811

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LRM 2000-09-11

ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST

Applicant Helix Diagnostics, Inc.

K number K001900

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LRM 2000-03-01

MDI DS-DNA TEST

Applicant Micro Detect, Inc.

K number K000477

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LRM 2000-02-18

DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM

Applicant Diamedix Corp.

K number K994424

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LRM 1999-12-21

BINDAZYME ANTI-DSDNA EIA KIT

Applicant The Binding Site, Ltd.

K number K993727

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LRM 1998-12-18

LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213

Applicant Bio-Rad

K number K984396

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LRM 1998-11-18

THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET

Applicant Zeus Scientific, Inc.

K number K983422

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LRM 1998-04-24

SERAQUEST ANTI-DSDNA

Applicant Quest Intl., Inc.

K number K980391

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LRM 1998-03-03

IS-DSDNA TEST SYSTEM

Applicant Diamedix Corp.

K number K974694

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LRM 1997-03-07

HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY

Applicant Hycor Biomedical, Inc.

K number K962730

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LRM 1997-03-04

AUTOSTATTMII ANTI-DSDNA

Applicant Cogent Diagnotics , Ltd.

K number K952567

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LRM 1996-03-20

DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM

Applicant Mardx Diagnostics, Inc.

K number K960182

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LRM 1996-03-20

ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT

Applicant Helix Diagnostics, Inc.

K number K960091

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LRM 1996-03-20

HYTEC AUTOMIMMUNE KIT (DS-DNA)

Applicant Hycor Biomedical, Inc.

K number K954893

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LRM 1995-11-09

ORGEN TEC ANTI-DSDNA ELISA ASSAY

Applicant Orgentec

K number K953671

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LRM 1995-07-18

ORGEN TEC ANTI-DSDNA PIN IMMUNO ASSAY

Applicant American Laboratory Products Co., Ltd.

K number K952055

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LRM 1995-04-17

VARELISA COMBINED DNA ANTIBODIES EIA

Applicant Elias U.S.A., Inc.

K number K944334

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LRM 1995-03-10

VARELISA DSDNA ANTIBODIES (FARR VERSION)

Applicant Elias U.S.A., Inc.

K number K950031

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LRM 1994-06-10

SELISA ANTI-N DNA ANTIBODIES

Applicant Cambridge Life Sciences Plc.

K number K940585

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LRM 1992-12-23

ENCORE DS-DNA

Applicant Clark Laboratories, Inc.

K number K923537

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LRM 1991-11-07

3M ANTI-DSDNA FAST TEST

Applicant 3M Diagnostic Systems, Inc.

K number K913653

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LRM 1991-09-23

ANTI-DNA MICROASSAY

Applicant Diamedix Corp.

K number K912020

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LRM 1990-07-16

UBI MAGIWEL(TM) ANTI-DS-DNA QUANTITATIVE

Applicant United Biotech, Inc.

K number K902897

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LRM 1989-06-02

ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS)

Applicant Amersham Corp.

K number K893036

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LRM 1987-12-18

NDNA ANTIBODY TEST KIT

Applicant Lipogen, Inc.

K number K874191

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LRM 1987-05-14

IMMUSTRIP(TM) DSDNA ELISA TEST SYSTEM

Applicant Immunomedics, Inc.

K number K870903

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