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.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Quest Diagnostics and its 4 subsidiaries with 110 510(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, Quest Diagnostics and its 4 subsidiaries
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 |
| Nov 18, 2016 | Quest Diagnostics HairCheck-DT (Cocaine)K152232 · DIO | 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 |
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
