FDA device listing
ANALYZER, CHEMISTRY
FDA device listing 1374856796 · Diamond Diagnostics Inc.
Key facts
| Proprietary names | ANALYZER, CHEMISTRY |
|---|---|
| Owner/operator | Diamond Diagnostics Inc. |
| Owner/operator number | 10028706 |
| Premarket submissions | K951595 |
| Product codes | CDQ, CDT, CEK, CEO, CET, CFN, CFR, CGX, CGZ, CHH, CIC, CIG and 50 more |
| Device names | CDQ - Urease And Glutamic Dehydrogenase, Urea Nitrogen, CDT - Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, CEK - Biuret (Colorimetric), Total Protein, CEO - Phosphomolybdate (Colorimetric), Inorganic Phosphorus, CET - Olive Oil Emulsion (Turbidimetric), Lipase, CFN - Method, Nephelometric, Immunoglobulins (G, A, M), CFR - Hexokinase, Glucose, CGX - Alkaline Picrate, Colorimetry, Creatinine, CGZ - Electrode, Ion-Specific, Chloride, CHH - Enzymatic Esterase--Oxidase, Cholesterol, CIC - Cresolphthalein Complexone, Calcium, CIG - Diazo Colorimetry, Bilirubin and 50 more |
| Device class | Class I, Class II, Unclassified |
| Classification regulations (21 CFR) | 862.1030, 862.1035, 862.1050, 862.1070, 862.1100, 862.1110, 862.1145, 862.1150, 862.1170, 862.1175, 862.1215, 862.1225 and 40 more |
| Review panels | Clinical Chemistry, Clinical Toxicology, Hematology, Immunology |
| Registered establishments | Diamond Diagnostics Inc. |
| Establishment registrations | 3006198300 |
| FEI numbers | 3006198300 |
| Establishment operations | Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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