LRM · Class II · 21 CFR 866.5100

FDA Product Code LRM: Anti-dna Antibody (enzyme-labeled), Antigen, Control

Leading manufacturers include Diamedix Corp., The Binding Site, Ltd. and Elias U.S.A., Inc..

29
Total
29
Cleared
112d
Avg days
1987
Since

FDA 510(k) Cleared Anti-dna Antibody (enzyme-labeled), Antigen, Control Devices (Product Code LRM)

29 devices
1–24 of 29
Cleared Dec 09, 2010
IMMULISA DSDNA ANTIBODY ELISA
K101319
Immco Diagnostics, Inc.
Immunology · 212d
Cleared Nov 21, 2006
FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT
K062183
The Binding Site, Ltd.
Immunology · 113d
Cleared Feb 18, 2000
DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM
K994424
Diamedix Corp.
Immunology · 50d
Cleared Dec 21, 1999
BINDAZYME ANTI-DSDNA EIA KIT
K993727
The Binding Site, Ltd.
Immunology · 57d
Cleared Dec 18, 1998
LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213
K984396
Bio-Rad
Immunology · 9d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET
K983422
Zeus Scientific, Inc.
Immunology · 50d
Cleared Mar 03, 1998
IS-DSDNA TEST SYSTEM
K974694
Diamedix Corp.
Immunology · 77d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY
K962730
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 04, 1997
AUTOSTATTMII ANTI-DSDNA
K952567
Cogent Diagnotics , Ltd.
Immunology · 638d
Cleared Mar 20, 1996
HYTEC AUTOMIMMUNE KIT (DS-DNA)
K954893
Hycor Biomedical, Inc.
Immunology · 147d
Cleared Jul 18, 1995
ORGEN TEC ANTI-DSDNA PIN IMMUNO ASSAY
K952055
American Laboratory Products Co., Ltd.
Immunology · 77d
Cleared Apr 17, 1995
VARELISA COMBINED DNA ANTIBODIES EIA
K944334
Elias U.S.A., Inc.
Immunology · 223d
Cleared Mar 10, 1995
VARELISA DSDNA ANTIBODIES (FARR VERSION)
K950031
Elias U.S.A., Inc.
Immunology · 65d
Cleared Sep 23, 1991
ANTI-DNA MICROASSAY
K912020
Diamedix Corp.
Immunology · 139d
Cleared Jun 02, 1989
ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS)
K893036
Amersham Corp.
Immunology · 39d

About Product Code LRM - Regulatory Context