Quest Diagnostics Nichols Institute
Country not established FDA FEI 3007521501
- Devices
- 69
- Registrations
- FDA
- FDA recalls
- 10
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
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.
Catalogue
Search and filter all 69 devicesShowing 1-50 of 69
Company details
- FDA FEI number
- 3007521501
- Address
- 33608 Ortega Hwy, San Juan Capistrano, CA, 92675
FDA recalls
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.
- 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.
- 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.
- 2 May 2005 Z-0873-05 Unclassified (pre-2012) Terminated Under recovery of diluted samples by as much as 20%.
- 28 Apr 2005 Z-0874-05 Unclassified (pre-2012) Terminated Does not meet performance claims in the labeling.
- 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.
- 14 Apr 2005 Z-0056-06 Unclassified (pre-2012) Terminated Controls were out of specification range.
- 7 Apr 2005 Z-0810-05 Unclassified (pre-2012) Terminated Values do not agree with Directional Instructions.
- 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.
Full distribution text
2004
- 30 Jun 2004 Z-1118-04 Unclassified (pre-2012) Terminated Lower than expected results are obtained.
Frequently asked questions
How many devices does Quest Diagnostics Nichols Institute have in the registry?
The registry currently lists 69 devices for Quest Diagnostics Nichols Institute. Devices recorded under merged duplicate company entries are counted once.
Which registries list Quest Diagnostics Nichols Institute's devices?
Among its 50 most recently registered devices, Quest Diagnostics Nichols Institute has devices listed in FDA 510(k) (50 devices).
What risk classes do Quest Diagnostics Nichols Institute's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Quest Diagnostics Nichols Institute's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Quest Diagnostics Nichols Institute?
FDA recall records list 10 recalls initiated by Quest Diagnostics Nichols Institute, the most recent initiated on 2005-09-30. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Quest Diagnostics Nichols Institute in the registry?
The most recently registered devices listed for Quest Diagnostics Nichols Institute include NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY, NICHOLS APO B CHEMILUMINESCENCE ASSAY, ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY and VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D.