Establishment registration
ROCHE MOLECULAR SYSTEMS, INC.
FDA establishment registration 3004141078 · PLEASANTON, US
Key facts
| Registration number | 3004141078 |
|---|---|
| Establishment name | ROCHE MOLECULAR SYSTEMS, INC. |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| FEI number | 3004141078 |
| Address | 4300 HACIENDA DRIVE |
| City | PLEASANTON |
| State | CA |
| Country | US |
| Establishment types | Manufacturer |
| Registration valid through | 2026 |
| Product codes listed | JJF, JJH, JQW, LSL, MAQ, MKT, MKZ, MZA, MZF, MZP, NQX, NSU, OCC, OOI, OQO, OWD, OZE, OZN, OZZ, PAB, PGX, PPM, PQA, QEP, QIH, QIV, QJR, QLT, QLX, QMI and 6 more |
| Device classes | 1, 2, 3, N |
At a glance
- 10–99 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