Product code DAP
- Device name
- Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.7320
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K172903 | HemosIL D-Dimer HS 500 | Instrumentation Laboratory CO | 2017-11-22 |
| K162227 | STA® - Liatest® D-Di | Diagnostica Stago | 2016-12-10 |
| K160885 | HemosIL D-Dimer HS | Instrumentation Laboratory CO | 2016-10-27 |
| K151534 | HemosIL D-Dimer HS | Instrumentation Laboratory CO | 2015-07-06 |
| K141144 | STA LIATEST D-DI | Diagnostica Stago | 2014-09-03 |
| K112818 | VIDAS D-DIMER EXCLUSION II (DEX2) | bioMerieux, Inc. | 2012-07-31 |
| K110303 | STRATUS CS ACUTE CARE D-DIMER | Siemens Healthcare Diagnostics | 2011-05-16 |
| K093626 | INNOVANCE D-DIMER, MODEL OPBP09 | Siemens Healthcare Diagnostics | 2010-11-29 |
| K090264 | HEMOSIL D-DIMER HS 500, CONTROLS | Instrumentation Laboratory CO | 2010-02-05 |
| K091916 | INNOVANCE D-DIMER, MODEL OPBP09 | Siemens Healthcare Diagnostics | 2009-10-29 |
| K081732 | INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS | Siemens Healthcare Diagnostics | 2008-10-24 |
| K073042 | HEMOSIL D-DIMER | Instrumentation Laboratory | 2008-07-31 |
| K080069 | DIMERTEST | American Diagnostica, Inc. | 2008-02-13 |
| K070927 | HEMOSIL D-DIMER HS | Instrumentation Laboratory CO | 2007-09-17 |
| K063356 | STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK | Dade Behring, Inc. | 2007-03-23 |
| K051597 | STRATUS CS D-DIMER | Dade Behring, Inc. | 2005-08-17 |
| K050544 | HEMOSIL D-DIMER HS | Instrumentation Laboratory CO | 2005-04-26 |
| K050278 | HEMOSIL D-DIMER | Instrumentation Laboratory CO | 2005-03-10 |
| K042723 | TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300 | Biosite Incorporated | 2004-12-07 |
| K033491 | ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS | Roche Diagnostics Corp. | 2004-09-01 |
| K041438 | ADVANCED D-DIMER ASSAY | Dade Behring, Inc. | 2004-08-11 |
| K040437 | TRIAGE PROFILER S.O.B. PANEL | Biosite Incorporated | 2004-06-25 |
| K040882 | VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442 | bioMerieux, Inc. | 2004-06-10 |
| K032419 | QUANTEX D-DIMER | Instrumentation Laboratory CO | 2003-10-24 |
| K030328 | VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442 | bioMerieux, Inc. | 2003-09-02 |
| K030687 | K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C | Kamiya Biomedical Co. | 2003-06-27 |
| K022976 | STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D | Dade Behring, Inc. | 2003-01-16 |
| K022977 | STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C | Dade Behring, Inc. | 2002-11-27 |
| K020810 | VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442 | bioMerieux, Inc. | 2002-10-03 |
| K012755 | AUTODIMER ASSAY MODEL # 1431 | Xtrana, Inc. | 2002-03-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00816870023878 | D-Dimer AccuLite CLIA Test System - 192 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870023885 | D-Dimer AccuLite CLIA Test System - 96 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870023892 | D-Dimer AccuBind ELISA Test System - 192 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870023908 | D-Dimer AccuBind ELISA Test System - 96 Wells | MONOBIND, INC. | 2024-09-13 |
| 00630414639666 | INNOVANCE® D-Dimer Sample Diluent | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00842768019265 | INNOVANCE® D-Dimer Sample Diluent | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414640181 | INNOVANCE D-Dimer Controls | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414640488 | INNOVANCE D-Dimer | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414640501 | INNOVANCE D-Dimer | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 05056080501666 | Thrombo-Wellcotest Glycine Saline | REMEL EUROPE LIMITED | 2021-07-21 |
| 08426951391615 | HemosIL D-Dimer HS 500 | INSTRUMENTATION LABORATORY COMPANY | 2019-06-10 |
| 00895160002502 | Fluoro-CheckTM D-Dimer | NANO-DITECH CORPORATION | 2019-05-24 |
| 30014613337959 | Triage | QUIDEL CARDIOVASCULAR INC. | 2018-11-01 |
| 00817089020542 | Diazyme | DIAZYME LABORATORIES, INC. | 2016-11-03 |
| 00893038002326 | Alere Triage® | Alere San Diego, Inc. | 2016-09-26 |
| 00899722002733 | Alere Triage® | Alere San Diego, Inc. | 2016-09-26 |
| 00899722002740 | Alere Triage® | Alere San Diego, Inc. | 2016-09-26 |
| 08426950060451 | HemosIL D-Dimer | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950358695 | HemosIL D-Dimer HS | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950485605 | HemosIL D-Dimer HS 500 | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950496946 | HemosIL AcuStar D-Dimer | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 04015630904204 | D-Dimer Control I/II | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630904105 | D-Dimer Calibrator | Roche Diagnostics GmbH | 2016-09-20 |
| 03607450005158 | STA® - Liatest® D-Di | DIAGNOSTICA STAGO | 2016-09-15 |
| 03607450005400 | FDP Plasma | DIAGNOSTICA STAGO | 2016-09-15 |
| 03607450009477 | Asserachrom® D-Di | DIAGNOSTICA STAGO | 2016-09-15 |
| 13607450005414 | FDP Plasma (Latex) | DIAGNOSTICA STAGO | 2016-09-15 |
| 13607450005513 | FDP Plasma (Buffer) | DIAGNOSTICA STAGO | 2016-09-15 |
| 00895160002151 | Nano-CheckTM D-Dimer | NANO-DITECH CORPORATION | 2016-09-14 |
| 03573026387006 | VIDAS® D-Dimer Exclusion II ™ | BIOMERIEUX SA | 2016-08-31 |