Panels › Immunology › Product code LRM · Class 2
Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
Regulation 866.5100
0510(k)s in 12 months (29 all time)
0recalls in 12 months (3 all time)
2recalls that name a 510(k)
Top companies in LRM
| Company | 510(k)s | Recalls |
|---|---|---|
| Diamedix Corp. | 3 | 0 |
| The Binding Site, Ltd. | 2 | 0 |
| Bio-Rad Laboratories Inc | 0 | 2 |
| Elias U.S.A., Inc. | 2 | 0 |
| Helix Diagnostics, Inc. | 2 | 0 |
| Hycor Biomedical, Inc. | 2 | 0 |
| 3M Diagnostic Systems, Inc. | 1 | 0 |
| American Laboratory Products Co., Ltd. | 1 | 0 |
| Amersham Corp. | 1 | 0 |
| Bio-Rad | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 9, 2010 | K101319 | IMMULISA DSDNA ANTIBODY ELISA Immco Diagnostics, Inc. | LRM |
| Apr 15, 2009 | K083381 | EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG) Euroimmun Us, Inc. | LRM |
| Nov 21, 2006 | K062183 | FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT The Binding Site, Ltd. | LRM |
| May 13, 2004 | K040811 | VARELISA SSDNA ANTIBODIES, MODEL 14896 Pharmacia Deutschland GmbH, DE | LRM |
| Sep 11, 2000 | K001900 | ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST Helix Diagnostics, Inc. | LRM |
| Mar 1, 2000 | K000477 | MDI DS-DNA TEST Micro Detect, Inc. | LRM |
| Feb 18, 2000 | K994424 | DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM Diamedix Corp. | LRM |
| Dec 21, 1999 | K993727 | BINDAZYME ANTI-DSDNA EIA KIT The Binding Site, Ltd. | LRM |
| Dec 18, 1998 | K984396 | LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213 Bio-Rad | LRM |
| Nov 18, 1998 | K983422 | THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET Zeus Scientific, Inc. | LRM |
| Apr 24, 1998 | K980391 | SERAQUEST ANTI-DSDNA Quest Intl., Inc. | LRM |
| Mar 3, 1998 | K974694 | IS-DSDNA TEST SYSTEM Diamedix Corp. | LRM |
| Mar 7, 1997 | K962730 | HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY Hycor Biomedical, Inc. | LRM |
| Mar 4, 1997 | K952567 | AUTOSTATTMII ANTI-DSDNA Cogent Diagnotics , Ltd., GB | LRM |
| Mar 20, 1996 | K960182 | DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM Mardx Diagnostics, Inc. | LRM |
| Mar 20, 1996 | K960091 | ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT Helix Diagnostics, Inc. | LRM |
| Mar 20, 1996 | K954893 | HYTEC AUTOMIMMUNE KIT (DS-DNA) Hycor Biomedical, Inc. | LRM |
| Nov 9, 1995 | K953671 | ORGEN TEC ANTI-DSDNA ELISA ASSAY Orgentec | LRM |
| Jul 18, 1995 | K952055 | ORGEN TEC ANTI-DSDNA PIN IMMUNO ASSAY American Laboratory Products Co., Ltd. | LRM |
| Apr 17, 1995 | K944334 | VARELISA COMBINED DNA ANTIBODIES EIA Elias U.S.A., Inc. | LRM |
| Mar 10, 1995 | K950031 | VARELISA DSDNA ANTIBODIES (FARR VERSION) Elias U.S.A., Inc. | LRM |
| Jun 10, 1994 | K940585 | SELISA ANTI-N DNA ANTIBODIES Cambridge Life Sciences Plc., GB | LRM |
| Dec 23, 1992 | K923537 | ENCORE DS-DNA Clark Laboratories, Inc. | LRM |
| Nov 7, 1991 | K913653 | 3M ANTI-DSDNA FAST TEST 3M Diagnostic Systems, Inc. | LRM |
| Sep 23, 1991 | K912020 | ANTI-DNA MICROASSAY Diamedix Corp. | LRM |
| Jul 16, 1990 | K902897 | UBI MAGIWEL(TM) ANTI-DS-DNA QUANTITATIVE United Biotech, Inc. | LRM |
| Jun 2, 1989 | K893036 | ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS) Amersham Corp. | LRM |
| Dec 18, 1987 | K874191 | NDNA ANTIBODY TEST KIT Lipogen, Inc. | LRM |
| May 14, 1987 | K870903 | IMMUSTRIP(TM) DSDNA ELISA TEST SYSTEM Immunomedics, Inc. | LRM |
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