Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Quest DiagnosticsLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Focus Diagnostics with 17 510(k) clearances and 11 device recalls. The most recent is a device recall dated Feb 15, 2017: Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-qu….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Feb 15, 2017 | Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneuClass II · After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found that their Le | Device recalls |
| Feb 15, 2017 | Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.Class II · After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found that their Le | Device recalls |
| Feb 14, 2017 | Simplexa C. difficile Direct; Simplexa C. difficile Positive Control PackK163085 · OZN | 510(k) clearances |
| Feb 10, 2016 | Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2850, MOL1451, MOL14Class I · Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150 | Device recalls |
| Feb 10, 2016 | Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2150, MOL1451, MOL1452, MOLClass I · Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150 | Device recalls |
| Feb 10, 2016 | Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2650, MOL1451, MOL14Class II · Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150 | Device recalls |
| Oct 2, 2015 | Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.Class II · Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase in invalid re | Device recalls |
| Sep 21, 2015 | Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control PackK152408 · OCC | 510(k) clearances |
| Aug 28, 2015 | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackK150962 · OQO | 510(k) clearances |
| Mar 18, 2015 | Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control PackK143651 · PGX | 510(k) clearances |
| Mar 15, 2015 | STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.Class II · Focus Diagnostics is recalling the Stratify JCV Dx Select due to the use of a non-conforming batch in the manufacture of | Device recalls |
| Dec 5, 2014 | Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control PackK142365 · OCC | 510(k) clearances |
| Jul 1, 2014 | SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACKK141458 · PGH | 510(k) clearances |
| May 15, 2014 | Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 Simplexa" Flu A/B & RSV Direct. The Focus Diagnostics SimplClass II · Focus Diagnostics is providing an urgent safety notice for a correction to the labeling for Simplexa" Flu A/B & RSV Dire | Device recalls |
| Mar 21, 2014 | SIMPLEXA HSV 1&2 DIRECTDEN130049 · PGH | 510(k) clearances |
| Aug 16, 2012 | STRATIFY JCV DXSELECTK120986 · OYP | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
