FDA Device Establishments · JSON-LD · Markdown

ORTHO-CLINICAL DIAGNOSTICS, INC.

FEI 1000136573 · Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 · Status: Active

FEI Number1000136573
Owner / OperatorQuidelOrtho Corporation (#2024674)
Address100 Indigo Creek Dr, Rochester, NY, US
Registration expiry2026
Initial importer flagN
Registered products3
Product codes (top 20)JJX, JIS, DDR
Regulation § (21 CFR)862.1660, 862.1150, 866.5680
Proprietary namesVITROS Myoglobin Range Verifier; VITROS Myoglobin Reagent Pack; VITROS Myoglobin Calibrator

External sources

Source: openFDA. Public-domain (CC0).