Panels › Hematology › Product code GHH · Class 2
Fibrin Split Products
Regulation 864.7320
0510(k)s in 12 months (28 all time)
0recalls in 12 months (9 all time)
8recalls that name a 510(k)
Top companies in GHH
| Company | 510(k)s | Recalls |
|---|---|---|
| Agen Biomedical , Ltd. | 3 | 0 |
| American Bioproducts Co. | 3 | 0 |
| Roche Diagnostics Corp. | 3 | 0 |
| Abbott Laboratories | 2 | 0 |
| Alere San Diego, Inc. | 0 | 2 |
| E.I. Dupont DE Nemours & Co., Inc. | 2 | 0 |
| American Dade | 1 | 0 |
| American Hospital Supply Corp. | 1 | 0 |
| BBI SOLUTIONS OEM LTD | 0 | 1 |
| Behring Diagnostics, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 20, 2023 | Roche Diagnostics Operations, Inc. Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus), 08105618190 - (cobas c 303 and 503) Open, Classified |
GHH | K062203 |
| Nov 21, 2016 | Lsi Medience Corporation Pathfast D-Dimer, Reference number: PF1051-KUS Terminated |
GHH | K072288 |
| Jun 1, 2016 | BBI SOLUTIONS OEM LTD SimpliRED D-Dimer, Product Code DSRK4
The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in Terminated |
GHH | K905643 |
| Jun 6, 2014 | Alere San Diego, Inc. Alere Triage D-Dimer Test
PN 98100, Lot W53884B.
The Alere Triage D-Dimer Test is a fluorescence immunoassay to be used with the Alere Triage Meters for the quantitative determination of cross-linked Terminated |
GHH | K042890 |
| Jul 6, 2012 | Alere San Diego, Inc. Triage D-dimer PN 98100
Used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism. Terminated |
GHH | K042890 |
| Oct 7, 2011 | Tcoag Us, Incorporated Minutex D-Dimer ; Trinity Biotech plc,
Bray,
Co. Wicklow,
Ireland.
Tel: (353) 1 276 9800,
Fax: (353) 1 276 9888,
Web: www.trinitybiotech.com
Minutex D-Dimer is a latex agglutination test for semiquan Terminated |
GHH | K920668 |
| Mar 13, 2007 | Inverness Medical Professional Diagnostics Clearview Simplify D-dimer, in vitro diagnostic for qualitative detection of D-dimer in human whole blood and plasma.
Product No. 61100KVC
10 test devices containing anti D-dimer monoclonal antibod Terminated |
GHH | K993276 |
| Jul 22, 2005 | Dade Behring , Inc. Dade Fibrin(ogen) Degradation Products (FDP) Detection Set. Catalog number B4233-10E Terminated |
GHH | K872360 |
| Aug 11, 2004 | Fisher Diagnostic, A Company of Fisher Scientific LLC Pacific Hemostasis D-Dimer Assay Kit, Fisher Diagnostics Catalog Number 100660, packaged in a cardboard box containing materials and reagents to perform 80 tests. Terminated |
GHH | None listed |
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