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Quest Diagnostics Nichols Institute

Also registered as Nichols Institute Diagnostics

United Statesfrom the FDA registration address FDA FEI 3007521501

Devices
69
Registrations
FDA
FDA recalls
10

What Quest Diagnostics Nichols Institute makes

The company develops and manufactures diagnostic tests, including the Quest Diagnostics AAVrh74 Antibody ELISA CDx, a laboratory-based enzyme-linked immunosorbent assay (ELISA) designed for detecting antibodies in patient samples. This test is intended for clinical decision-making in autoimmune and rheumatological conditions, providing quantitative measurement of specific antibody levels. The portfolio focuses on specialized immunoassays for autoimmune disease monitoring and diagnosis.

The portfolio is regulated under Class III devices in the United States, requiring Premarket Approval (PMA) authorization through the FDA. The company’s devices are listed in the FDA’s PMA registry, adhering to stringent premarket review requirements for high-risk diagnostic products. The manufacturer operates from the United States, where its products are subject to U.S. regulatory oversight.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue69

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Company details

FDA FEI number
3007521501
Address
33608 Ortega Hwy, San Juan Capistrano, CA, 92675

FDA recalls10

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

  • 2005

    • 30 Sep 2005 Z-0136-06 Unclassified (pre-2012) Terminated Some units in Lot 30-500953 (Calibration Verifier 2) are mislabeled as Calibration Verifier 3. Some units of Lot 30-500953 (Calibration Verifier 3) are mislabeled as Calibration Verifier 2. Distribution: CA, IN, WA
    • 31 Aug 2005 Z-0006-06 Unclassified (pre-2012) Terminated Data from internal testing indicates that the Nichols Advantage Invasive Trophoblast Antigen Assay Cartridges (ITA)(Lot No 62-500261) and Hyperglycosylated Human Chorionic Gonadotropin Assay Cartridges (H-hCG)(Lot No 62-500262) does not maintain its stability over the 12 month expiration dating of the product, and that stability is assured only through 6 months. Distribution: Nationwide and China, Germany, & Australia
    • 31 Aug 2005 Z-0007-06 Unclassified (pre-2012) Terminated Data from internal testing indicates that the Nichols Advantage Invasive Trophoblast Antigen Assay Cartridges (ITA)(Lot No 62-500261) and Hyperglycosylated Human Chorionic Gonadotropin Assay Cartridges (H-hCG)(Lot No 62-500262) does not maintain its stability over the 12 month expiration dating of the product, and that stability is assured only through 6 months. Distribution: Nationwide and China, Germany, & Australia Submission number: K042676
    • 2 May 2005 Z-0873-05 Unclassified (pre-2012) Terminated Under recovery of diluted samples by as much as 20%. Distribution: Nationwide and to Germany, Sweden, Italy, japan, Spain
    • 28 Apr 2005 Z-0874-05 Unclassified (pre-2012) Terminated Does not meet performance claims in the labeling. Distribution: Nationwide, Germany, Greece and Spain
    • 22 Apr 2005 Z-1044-05 Unclassified (pre-2012) Terminated Performance does not meet claims in the Directional Insert concerning correlation with the IRMA ACTH assay. Distribution: Nationwide and Hungary, Poland, Australia, Canada, Germany, Greece, Italy, Spain, Sweden Submission number: K962601
    • 14 Apr 2005 Z-0056-06 Unclassified (pre-2012) Terminated Controls were out of specification range. Distribution: Nationwide, Japan, Spain, Germany and Sweden
    • 7 Apr 2005 Z-0810-05 Unclassified (pre-2012) Terminated Values do not agree with Directional Instructions. Distribution: Nationwide and to Australia, Canada, Chile, France, Germany, Greece, Italy, japan, Spain, Sweden Submission number: K033727
    • 25 Mar 2005 Z-0809-05 Unclassified (pre-2012) Terminated Firm noted a change in performance and therefore changed the labeled performance specifications in the Directional Insert portion of the labeling. Distribution: Nationwide, Canada, Greece, Italy, Sweden, Austria, Balgium, Korea, Spain, Grea Britian, Taiwan, Finland, Denmark, New…
      Full distribution text Nationwide, Canada, Greece, Italy, Sweden, Austria, Balgium, Korea, Spain, Grea Britian, Taiwan, Finland, Denmark, New Zealand, Israel
      Submission number: K861797

  • 2004

    • 30 Jun 2004 Z-1118-04 Unclassified (pre-2012) Terminated Lower than expected results are obtained. Distribution: Nationwide. Canada, Australia, Greece, Denmark, Portugal, Sweden, Brazil, Italy, japan, Spain, Germany, France. Submission number: K012367