FDA device listing
cobas INTEGRA TOTAL MPA CALIBRATOR SET,cobas INTEGRA TOTAL MPA CONTROL SET,cobas MPA,MPA, 100Tests, cobas c…
FDA device listing 1097523556 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | cobas INTEGRA TOTAL MPA CALIBRATOR SET,cobas INTEGRA TOTAL MPA CONTROL SET,cobas MPA,MPA, 100Tests, cobas c 503,Mycophenolic Acid,ROCHE TOTAL MYCOPHENOLIC ACID ASSAY,Total MPA Reagents,Total Mycophenolic Acid |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Premarket submissions | K063520 |
| Product codes | DLJ, LAS, OAV |
| Device names | DLJ - Calibrators, Drug Specific, LAS - Drug Specific Control Materials, OAV - Mycophenolic Acid Test System |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.3200, 862.3280, 862.3840 |
| Review panels | Clinical Toxicology |
| Registered establishments | ROCHE DIAGNOSTICS GMBH |
| Establishment registrations | 9610126 |
| FEI numbers | 3002806559 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database