FDA Registration
Active
🇭🇺 Hungary
ANALYZER, CHEMISTRY
Reg #: 3006198300
·
FEI: 3006198300
·
Expires 2025
Products
62
Proprietary Names
1
Establishment Types
1
Classifications
62
Registration Details
- Registration Name
- Diamond Diagnostics Inc.
- Registration Number
- 3006198300
- FEI Number
- 3006198300
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6 Oradna Street
- City
- Budapest
- Country
- HU
Regulatory Submissions
- 510(k) Number
- K951595
Owner / Operator
- Firm Name
- Diamond Diagnostics Inc.
- Operator Number
- 10028706
- Address
- 333 Fiske St
- City
- Holliston
- State
- MA
- Postal Code
- 01746
- Country
- US
- Correspondent
- Kathy Fisher
US Agent
- Business Name
- DIAMOND DIAGNOSTICS INC.
- Contact Name
- Kathy Fisher
- Address
- 333 Fiske St
- City
- Holliston
- State
- MA
- ZIP
- 01746
- Country
- US
- [email protected]
- Phone
- 508 4290450 ext. 358
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Colorimetry, Cholinesterase | DIH | Class 1 | Clinical Toxicology | No | 2020-03-27 |
| Alkaline Picrate, Colorimetry, Creatinine | CGX | Class 2 | Clinical Chemistry | No | 2020-03-27 |
| Kinetic Method, Gamma-Glutamyl Transpeptidase | JQB | Class 1 | Clinical Chemistry | No | 2020-03-27 |
| Calibrators, Drug Mixture | DKB | Class 2 | Clinical Toxicology | No | 2020-03-27 |
| Photometric Method, Magnesium | JGJ | Class 1 | Clinical Chemistry | No | 2020-03-27 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2020-03-27 |
| Enzyme Immunoassay, Quinidine | LBZ | Class 2 | Clinical Toxicology | No | 2020-03-27 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2020-03-27 |
| Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | DIC | Class 2 | Clinical Toxicology | No | 2020-03-27 |
| Method, Nephelometric, Immunoglobulins (G, A, M) | CFN | Class 2 | Immunology | No | 2020-03-27 |
| Cresolphthalein Complexone, Calcium | CIC | Class 2 | Clinical Chemistry | No | 2020-03-27 |
| Photometric Method, Iron (Non-Heme) | JIY | Class 1 | Clinical Chemistry | No | 2020-03-27 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2020-03-27 |
| Lipoprotein X, Antigen, Antiserum, Control | DEL | Class 1 | Immunology | No | 2020-03-27 |
| Phosphomolybdate (Colorimetric), Inorganic Phosphorus | CEO | Class 1 | Clinical Chemistry | No | 2020-03-27 |
| Differential Rate Kinetic Method, Cpk Or Isoenzymes | JHS | Class 2 | Clinical Chemistry | No | 2020-03-27 |
| Enzyme Immunoassay, Procainamide | LAR | Class 2 | Clinical Toxicology | No | 2020-03-27 |
| Turbidimetric Method, Lipoproteins | JHN | Class 1 | Clinical Chemistry | No | 2020-03-27 |
| Biuret (Colorimetric), Total Protein | CEK | Class 2 | Clinical Chemistry | No | 2020-03-27 |
| Drug Specific Control Materials | LAS | Class 1 | Clinical Toxicology | No | 2020-03-27 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2020-03-27 |
| Enzyme Immunoassay, Phenobarbital | DLZ | Class 2 | Clinical Toxicology | No | 2020-03-27 |
| Enzyme Immunoassay, Digoxin | KXT | Class 2 | Clinical Toxicology | No | 2020-03-27 |
| Complement C3, Antigen, Antiserum, Control | CZW | Class 2 | Immunology | No | 2020-03-27 |
| Radioassay, Triiodothyronine Uptake | KHQ | Class 2 | Clinical Chemistry | No | 2020-03-27 |
| Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | KLI | Class 2 | Clinical Chemistry | No | 2020-03-27 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2020-03-27 |
| Enzyme Immunoassay, N-Acetylprocainamide | LAN | Class 2 | Clinical Toxicology | No | 2020-03-27 |
| System, Test, Urinary Methylmalonic Acid | LPT | Class 2 | Clinical Chemistry | No | 2020-03-27 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2020-03-27 |
| Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | CDT | Class 1 | Clinical Chemistry | No | 2020-03-27 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2020-03-27 |
| Drug Mixture Control Materials | DIF | Class 1 | Clinical Toxicology | No | 2020-03-27 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2020-03-27 |
| Nadh Oxidation/Nad Reduction, Ast/Sgot | CIT | Class 2 | Clinical Chemistry | No | 2020-03-27 |
| Enzyme Immunoassay, Valproic Acid | LEG | Class 2 | Clinical Toxicology | No | 2020-03-27 |
| Complement C4, Antigen, Antiserum, Control | DBI | Class 2 | Immunology | No | 2020-03-27 |
| Nephelometer | JZW | Class 1 | Immunology | No | 2020-03-27 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2020-03-27 |
| Hexokinase, Glucose | CFR | Class 2 | Clinical Chemistry | No | 2020-03-27 |
| Fluorescence Polarization Immunoassay, Phenobarbital | LGQ | Class 2 | Clinical Toxicology | No | 2020-03-27 |
| Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | CJE | Class 2 | Clinical Chemistry | No | 2020-03-27 |
| Urease And Glutamic Dehydrogenase, Urea Nitrogen | CDQ | Class 2 | Clinical Chemistry | No | 2020-03-27 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2020-03-27 |
| System, Test, C-Reactive Protein | DCN | Class 2 | Immunology | No | 2020-03-27 |
| Fluorescence Polarization Immunoassay, Theophylline | LGS | Class 2 | Clinical Toxicology | No | 2020-03-27 |
| Bromcresol Green Dye-Binding, Albumin | CIX | Class 2 | Clinical Chemistry | No | 2020-03-27 |
| Igg, Antigen, Antiserum, Control | DEW | Class 2 | Immunology | No | 2020-03-27 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2020-03-27 |
| Catalytic Methods, Amylase | JFJ | Class 2 | Clinical Chemistry | No | 2020-03-27 |
| Olive Oil Emulsion (Turbidimetric), Lipase | CET | Class 1 | Clinical Chemistry | No | 2020-03-27 |
| Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free) | MOJ | Class 2 | Clinical Toxicology | No | 2020-03-27 |
| Calibrators, Drug Specific | DLJ | Class 2 | Clinical Toxicology | No | 2020-03-27 |
| Iga, Antigen, Antiserum, Control | CZP | Class 2 | Immunology | No | 2020-03-27 |
| Enzyme Immunoassay, Cocaine | JXO | Class 2 | Clinical Toxicology | No | 2020-03-27 |
| Fluorescence Polarization Immunoassay, Carbamazepine | LGI | Class 2 | Clinical Toxicology | No | 2020-03-27 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2020-03-27 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2020-03-27 |
| Assay, Glycosylated Hemoglobin | LCP | Class 2 | Hematology | No | 2020-03-27 |
| Transferrin, Antigen, Antiserum, Control | DDG | Class 2 | Immunology | No | 2020-03-27 |
| Diazo Colorimetry, Bilirubin | CIG | Class 2 | Clinical Chemistry | No | 2020-03-27 |
| Nadh Oxidation/Nad Reduction, Alt/Sgpt | CKA | Class 1 | Clinical Chemistry | No | 2020-03-27 |
Proprietary Names
ANALYZER, CHEMISTRY
Establishment Types
Export Device to the United States But Perform No Other Operation on Device