Establishment registration
ORTHO-CLINICAL DIAGNOSTICS, INC.
FDA establishment registration 1319681 · Rochester, US
Key facts
| Registration number | 1319681 |
|---|---|
| Establishment name | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| Owner/operator | QuidelOrtho Corporation |
| Owner/operator number | 2024674 |
| FEI number | 1000136573 |
| Address | 100 Indigo Creek Dr |
| City | Rochester |
| State | NY |
| Country | US |
| Registration valid through | 2026 |
| Product codes listed | CDD, CDN, CDP, CDT, CDZ, CEC, CEK, CEM, CEO, CEP, CEW, CFJ, CFN, CFT, CGA, CGJ, CGN, CGR, CGZ, CHH, CHI, CHP, CIG, CIT, CIW, CIX, CJE, CJY, CKA, CZW and 107 more |
| Device classes | 1, 2, N, U |
At a glance
- 100–999 Device listings
- 1,000+ UDI devices (GUDID)
- Current Registration current
- 10–99 FDA inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device establishment registrations
Device establishments that manufacture, repackage, relabel or import devices for the U.S. market must register annually with the FDA and list the devices they produce.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database