Panels › Hematology › Product code NPQ · Class 2
Test, Factor V Leiden Mutations, Genomic Dna Pcr
Regulation 864.7280
0510(k)s in 12 months (6 all time)
0recalls in 12 months (14 all time)
3recalls that name a 510(k)
Top companies in NPQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Roche Diagnostics Corp. | 1 | 9 |
| Synthes Spine | 0 | 2 |
| AutoGenomics, Inc. | 1 | 0 |
| Cepheid | 1 | 0 |
| Hologic, Inc. | 1 | 0 |
| Illumina, Inc. | 1 | 0 |
| Osmetech Molecular Diagnostics | 1 | 0 |
| Roche Diagnostics Operations, Inc. | 0 | 1 |
| Roche Molecular Systems, Inc. | 0 | 1 |
| Zimmer, Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2012 | Zimmer, Inc. Dynesys L.I.S. Stabilizing cord
Rx, Sterile Terminated |
NPQ | K031511 |
| Jun 14, 2011 | Roche Molecular Systems, Inc. Factor V Leiden Kit Light Cycler Instrument; Manufactured in Germany for Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA; Distributed by Roche Diagnostics Indianapolis, IN 46266 USA; 0361017900 Terminated |
NPQ | None listed |
| Mar 14, 2011 | Roche Diagnostics Operations, Inc. Factor V Leiden kit catalog number 03610179001, Roche Diagnostics, Indianapolis, IN
The Factor V Leiden Kit allows the detection and genotyping of a single point mutation (G to A at position 1691) Terminated |
NPQ | None listed |
| Feb 3, 2009 | Synthes Spine NFlex Stabilization System 150 mm, Catalog number NF60150-1.
spinal fusion surgery Terminated |
NPQ | K072685 |
| Feb 3, 2009 | Synthes Spine NFlex Stabilization System 200 mm, Catalog number NF60020-1.
spinal fusion surgery Terminated |
NPQ | K072685 |
| Jun 22, 2007 | Roche Diagnostics Corp. MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog # 03264793001. Terminated |
NPQ | None listed |
| Aug 5, 2006 | Roche Diagnostics Corp. Roche MagNA Pure LC Instrument; Catalog nos. 12236931444, 12236931692 ( Refurbished) and 12236931690 (Return). An automated, general purpose instrument for isolation and purification of nucleic acids Terminated |
NPQ | None listed |
| Aug 5, 2006 | Roche Diagnostics Corp. Roche MagNA Pure LC Instrument Kit; Catalog no. 12236931001. An automated, general purpose instrument for isolation and purification of nucleic acids and assembly of PCR reactions. Terminated |
NPQ | None listed |
| Aug 5, 2006 | Roche Diagnostics Corp. Roche MagNA Pure LC System (RMD); Catalog no. 03670325001. An automated, general purpose instrument for isolation and purification of nucleic acids and assembly of PCR reactions. Terminated |
NPQ | None listed |
| Apr 19, 2006 | Roche Diagnostics Corp. Roche MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog number 03264793001. Terminated |
NPQ | None listed |
| Apr 19, 2006 | Roche Diagnostics Corp. Roche MagNA Pure LC DNA Isolation Kit - Large Volume; Catalog number 03310515001. Terminated |
NPQ | None listed |
| Apr 19, 2006 | Roche Diagnostics Corp. Roche MagNA Pure LC System. An automated, general purpose instrument for isolation and purification of nucleic acids and assembly of PCR reactions. Catalog numbers 12236931001 and 03670325001 Terminated |
NPQ | None listed |
| Dec 8, 2004 | Roche Diagnostics Corp. MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001. Terminated |
NPQ | None listed |
| Aug 17, 2004 | Roche Diagnostics Corp. MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001. Terminated |
NPQ | None listed |
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