FDA Registration
Active
🇺🇸 United States
Infinity Creatinine
Reg #: 1181121
·
FEI: 1181121
·
Expires 2025
Products
13
Proprietary Names
2
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- Fisher Diagnostics
- Registration Number
- 1181121
- FEI Number
- 1181121
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 8365 VALLEY PIKE
- City
- MIDDLETOWN
- State
- VA
- ZIP
- 22645
- Country
- US
Regulatory Submissions
- 510(k) Number
- K973869
Owner / Operator
- Firm Name
- Thermo Fisher Scientific
- Operator Number
- 2517925
- Address
- 168 Third Avenue, --
- City
- Waltham
- State
- MA
- Postal Code
- 02451
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Alkaline Picrate, Colorimetry, Creatinine | CGX | Class 2 | Clinical Chemistry | No | 2008-01-08 |
| Catalytic Methods, Amylase | JFJ | Class 2 | Clinical Chemistry | No | 2008-01-08 |
| Diazo Colorimetry, Bilirubin | CIG | Class 2 | Clinical Chemistry | No | 2008-01-08 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2008-01-08 |
| Colorimetric Method, Triglycerides | JGY | Class 1 | Clinical Chemistry | No | 2008-01-08 |
| Biuret (Colorimetric), Total Protein | CEK | Class 2 | Clinical Chemistry | No | 2008-01-08 |
| Ferrozine (Colorimetric) Iron Binding Capacity | JMO | Class 1 | Clinical Chemistry | No | 2008-01-08 |
| Enzymatic, Carbon-Dioxide | KHS | Class 2 | Clinical Chemistry | No | 2008-01-08 |
| Nadh Oxidation/Nad Reduction, Ast/Sgot | CIT | Class 2 | Clinical Chemistry | No | 2008-01-08 |
| Nadh Oxidation/Nad Reduction, Alt/Sgpt | CKA | Class 1 | Clinical Chemistry | No | 2008-01-08 |
| Acid, Uric, Uricase (Colorimetric) | KNK | Class 1 | Clinical Chemistry | No | 2008-01-08 |
| Photometric Method, Iron (Non-Heme) | JIY | Class 1 | Clinical Chemistry | No | 2008-01-08 |
| Urease And Glutamic Dehydrogenase, Urea Nitrogen | CDQ | Class 2 | Clinical Chemistry | No | 2008-01-08 |
Proprietary Names
Infinity Creatinine
Creatinine
Establishment Types
Manufacture Medical Device