Atlas FDA

LRM

29 FDA 510(k) clearances · Product code

77 daysmedian time to decision
223 days90th percentile
29clearances measured

FDA profile

Official device name
Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5100
Medical specialty
Immunology
Flags
Third-party review eligible
Adverse events (MAUDE)
2002: 4 · 2003: 6 · 2004: 2 · 2005: 5 · 2007: 15 · 2008: 28
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
IMMULISA DSDNA ANTIBODY ELISA (K101319)Immco Diagnostics, Inc.2010-12-09
EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG) (K083381)Euroimmun Us, Inc.2009-04-15
FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT (K062183)The Binding Site, Ltd.2006-11-21
VARELISA SSDNA ANTIBODIES, MODEL 14896 (K040811)Pharmacia Deutschland GmbH2004-05-13
ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST (K001900)Helix Diagnostics, Inc.2000-09-11
MDI DS-DNA TEST (K000477)Micro Detect, Inc.2000-03-01
DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM (K994424)Diamedix Corp.2000-02-18
BINDAZYME ANTI-DSDNA EIA KIT (K993727)The Binding Site, Ltd.1999-12-21
LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213 (K984396)Bio-Rad1998-12-18
THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET (K983422)Zeus Scientific, Inc.1998-11-18
SERAQUEST ANTI-DSDNA (K980391)Quest Intl., Inc.1998-04-24
IS-DSDNA TEST SYSTEM (K974694)Diamedix Corp.1998-03-03
HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY (K962730)Hycor Biomedical, Inc.1997-03-07
AUTOSTATTMII ANTI-DSDNA (K952567)Cogent Diagnotics , Ltd.1997-03-04
DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM (K960182)Mardx Diagnostics, Inc.1996-03-20
ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT (K960091)Helix Diagnostics, Inc.1996-03-20
HYTEC AUTOMIMMUNE KIT (DS-DNA) (K954893)Hycor Biomedical, Inc.1996-03-20
ORGEN TEC ANTI-DSDNA ELISA ASSAY (K953671)Orgentec1995-11-09
ORGEN TEC ANTI-DSDNA PIN IMMUNO ASSAY (K952055)American Laboratory Products Co., Ltd.1995-07-18
VARELISA COMBINED DNA ANTIBODIES EIA (K944334)Elias U.S.A., Inc.1995-04-17
VARELISA DSDNA ANTIBODIES (FARR VERSION) (K950031)Elias U.S.A., Inc.1995-03-10
SELISA ANTI-N DNA ANTIBODIES (K940585)Cambridge Life Sciences Plc.1994-06-10
ENCORE DS-DNA (K923537)Clark Laboratories, Inc.1992-12-23
3M ANTI-DSDNA FAST TEST (K913653)3M Diagnostic Systems, Inc.1991-11-07
ANTI-DNA MICROASSAY (K912020)Diamedix Corp.1991-09-23
UBI MAGIWEL(TM) ANTI-DS-DNA QUANTITATIVE (K902897)United Biotech, Inc.1990-07-16
ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS) (K893036)Amersham Corp.1989-06-02
NDNA ANTIBODY TEST KIT (K874191)Lipogen, Inc.1987-12-18
IMMUSTRIP(TM) DSDNA ELISA TEST SYSTEM (K870903)Immunomedics, Inc.1987-05-14

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Every clearance here is in the API, with alerts when new ones post.