Panels › Hematology › Product code DAP · Class 2
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Regulation 864.7320
1510(k)s in 12 months (58 all time)
2recalls in 12 months (13 all time)
11recalls that name a 510(k)
Top companies in DAP
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 19, 2026 | Diagnostica Stago, Inc. Brand Name: STA Liatest D-Di
Product Name: STA Liatest D-Di
Model/Catalog Number: REF 00515
Product Description: in vitro diagnostic. The STA - Liatest D-Di kit is an assay for the quantitative det Open, Classified |
DAP | K162227 |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB D-Dimer Test Open, Classified |
DAP | None listed |
| Oct 16, 2025 | Diagnostica Stago, Inc. Product: STA Liatest D-Di;
REF: 00515; Open, Classified |
DAP | K141144 K162227 +1 |
| Sep 22, 2021 | bioMerieux, Inc. VIDAS DEX@, Dimer Exclusion II, REF 30455-01 Open, Classified |
DAP | K141133 |
| Jan 7, 2016 | Siemens Healthcare Diagnostics Inc Siemens Acute Care DDMR TestPak
Catalog Number: CDDMRE
SMN: 10701511
in vitro diagnostic Terminated |
DAP | K110303 |
| Aug 14, 2014 | BioMerieux SA VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products in human plasma using the Enz Terminated |
DAP | K112818 |
| Aug 28, 2012 | Siemens Healthcare Diagnostics, Inc. Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002
The Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDMR CalPak), Catalog No. CDDMR-C is an in-vitro Terminated |
DAP | K063356 |
| Jul 6, 2012 | Alere San Diego, Inc. Alere Triage Profiler SOB Panel PN 97300
Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D Terminated |
DAP | K080269 |
| May 19, 2006 | Dade Behring , Inc. Stratus CS STAT Fluorometric Analyzer DDMR DilPak (CDDMR-D) in vitro diagnostic. Terminated |
DAP | K022976 |
| May 19, 2006 | Dade Behring , Inc. Stratus CS STAT Fluorometric Analyzer DDMR TestPak (CDDMR) in vitro diagnostic. Terminated |
DAP | K051597 |
| Nov 18, 2005 | Dade Behring , Inc. Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIMA method. Terminated |
DAP | K041438 |
| Feb 15, 2005 | Dade Behring , Inc. Advanced D-Dimer. Fibrinogen and fibrin split products Catalog numbers OQWM11 and OQEM13. Terminated |
DAP | K041438 |
| Jul 20, 2004 | Diagnostica Stago, Inc. FDP Plasma kit provides reagents for the detection and semi-quantitation of fibrin/fibrinogen degradation products (FDP) in plasma through the use of latex particles coated with monoclonal antibodies Terminated |
DAP | None listed |
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