Focus Diagnostics, Inc.
Medical device manufacturer in Cypress, CA.
16510(k) clearances
0PMA approvals
12recalls
Device types
- OCC Respiratory Virus Panel Nucleic Acid Assay… 4
- MXJ Enzyme Linked Immunosorbent Assay, Herpes… 3
- LSE Epstein-Barr Virus, Other 1
- LJN Antibody Igm, If, Epstein-Barr Virus 1
- OQW 2009 H1n1 Influenza Virus (Swine Origin)… 1
- OOI Real Time Nucleic Acid Amplification System 1
- OMN C. Difficile Nucleic Acid Amplification… 1
- OYP Anti-Jcv Antibody Detection Assay 1
- PGH Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel 1
- PGX Groups A, C And G Beta-Hemolytic… 1
- OQO Herpes Simplex Virus Nucleic Acid… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K152408 | Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control PackOCC · Special | 09/21/2015SE |
| K150962 | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackOQO · Traditional | 08/28/2015SE |
| K143651 | Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control PackPGX · Traditional | 03/18/2015SE |
| K142365 | Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control PackOCC · Traditional | 12/05/2014SE |
| K141458 | Simplexa HSV 1&2 Direct/Positive Control PackPGH · Special | 07/01/2014SE |
| K120986 | Stratify JCV DxselectOYP · Traditional | 08/16/2012SE |
| K120413 | Simplexa Flu A/B & RSV Direct, Simplexa Flu A/B & RSV Positive Control PackOCC · Traditional | 07/13/2012SE |
| K113433 | Simplexa C. Difficile Universal DirectOMN · Traditional | 04/04/2012SE |
| K102170 | Simplexa Flu A/B & RSVOCC · Traditional | 11/24/2010SE |
| K102314 | 3M Integrated Cycler (110V) & (220V)OOI · Traditional | 10/29/2010SE |
| K100148 | Simplexa Influenza a H1N1 (2009) Model MOL2500OQW · Traditional | 05/24/2010SE |
| K073381 | Plexus Ebv Igm Multi-Analyte Diagnostics, Model: MP0600MLJN · Traditional | 08/04/2008SE |
| K073382 | Plexus Ebv Igg Multi-Analyte Diagnostics, Model: MP0500GLSE · Traditional | 07/28/2008SE |
| K071511 | Plexus Herpeselect 1 and 2 Igg (with Plexus TM Software), Model MP0900GMXJ · Traditional | 10/05/2007SE |
| K071510 | Herpeselect Express Igg, Herpeselect Express Controls, Models RT0920G, RT0950MXJ · Traditional | 09/24/2007SE |
| K062543 | Herpeselect 1 and 2 Plexus Igg, Model MP0900GMXJ · Traditional | 02/01/2007SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1686-2017 Class II | Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and…After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found… | 02/15/2017Terminated |
| Z-1685-2017 Class II | Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human…After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found… | 02/15/2017Terminated |
| Z-1274-2016 Class I | Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451…Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2… | 02/10/2016Terminated |
| Z-1273-2016 Class II | Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451…Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2… | 02/10/2016Terminated |
| Z-1272-2016 Class I | Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452…Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2… | 02/10/2016Terminated |
| Z-0238-2016 Class II | Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro…Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase… | 10/02/2015Terminated |
| Z-1454-2015 Class II | STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus…Focus Diagnostics is recalling the Stratify JCV Dx Select due to the use of a non-conforming batch in the… | 03/15/2015Terminated |
| Z-1958-2014 Class II | Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 Simplexa" Flu A/B…Focus Diagnostics is providing an urgent safety notice for a correction to the labeling for Simplexa" Flu… | 05/15/2014Terminated |
| Z-1144-2014 Class II | Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential…Focus Diagnostics initiated the recall of the certain Simplexa Flu AlB & RSV Direct assay kits due to the… | 02/04/2014Terminated |
| Z-0846-2014 Class II | Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu…Focus Diagnostics is initiating an urgent safety notice correction for Simplexa Flu A/B & RSV Direct assay… | 01/10/2014Terminated |
| Z-0182-2013 Class III | West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641…The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a… | 10/03/2012Terminated |
| Z-1764-2008 | HerpeSelect 1 and 2 Immunoblot IgG Kit, IB0900G Intended for qualitatively detecting the…A small percentage of samples tested in specific lots, the HSV common antigen band appears lighter (less… | 07/06/2007Terminated |