FDA device listing
Diazyme hsCRP Assay,Diazyme hsCRP Calibrator Set,Diazyme hsCRP Control Set
FDA device listing 1996744983 · Diazyme Laboratories, Inc.
Key facts
| Proprietary names | Diazyme hsCRP Assay,Diazyme hsCRP Calibrator Set,Diazyme hsCRP Control Set |
|---|---|
| Owner/operator | Diazyme Laboratories, Inc. |
| Owner/operator number | 9057184 |
| Premarket submissions | K103557 |
| Product codes | DCK, JIT, JJX |
| Device names | DCK - C-Reactive Protein, Antigen, Antiserum, And Control, JIT - Calibrator, Secondary, JJX - Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1150, 862.1660, 866.5270 |
| Review panels | Clinical Chemistry, Immunology |
| Registered establishments | Diazyme Laboratories, Inc. |
| Establishment registrations | 2032900 |
| FEI numbers | 3004445302 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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