Data / Medical devices / United States / Quest Diagnostics Nichols Institute
Quest Diagnostics Nichols Institute: FDA-registered device maker in San Juan Capistrano, CA, United States, 1 PMA approval
Quest Diagnostics Nichols Institute is registered with the FDA (registration 3007521501) in San Juan Capistrano, CA, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated July 24, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007521501
- Address
- 33608 Ortega Hwy, San Juan Capistrano, CA, United States, 92675
- Owner or operator
- QUEST DIAGNOSTICS INCORPORATED (10028646)
- Roles
- Manufacturer
- First device listed
- July 28, 2026
- Registered through
- 2026
- Brand names listed
- Quest Diagnostics AAVrh74 Antibody ELISA CDx
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors | QWQ | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| July 24, 2025 | P250002 | Quest Diagnostics AAVrh74 Antibody ELISA CDx | QWQ | 0 | July 24, 2025 | accessdata.fda.gov |
Updated July 24, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.