FDA Registration
Active
🇺🇸 United States
Dimension Vista GGT Flex
Reg #: 2517506
·
FEI: 2517506
·
Expires 2025
Products
20
Proprietary Names
17
Establishment Types
1
Classifications
20
Registration Details
- Registration Name
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- Registration Number
- 2517506
- FEI Number
- 2517506
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 500 GBC DR, PO Box 6101
- City
- NEWARK
- State
- DE
- ZIP
- 19714
- Country
- US
Regulatory Submissions
- 510(k) Number
- K061655
Owner / Operator
- Firm Name
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- Operator Number
- 9096044
- Address
- Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue
- City
- Tarrytown
- State
- NY
- Postal Code
- 10591
- Country
- US
- Correspondent
- Mary Seeger
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Acid, Uric, Uricase (Colorimetric) | KNK | Class 1 | Clinical Chemistry | No | 2007-11-15 |
| Differential Rate Kinetic Method, Cpk Or Isoenzymes | JHS | Class 2 | Clinical Chemistry | No | 2007-11-15 |
| Enzyme Immunoassay, Lidocaine | KLR | Class 2 | Clinical Toxicology | No | 2007-11-15 |
| Colorimetry, Acetaminophen | LDP | Class 2 | Clinical Toxicology | No | 2007-11-15 |
| Enzyme Immunoassay, Valproic Acid | LEG | Class 2 | Clinical Toxicology | No | 2007-11-15 |
| Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | KLI | Class 2 | Clinical Chemistry | No | 2007-11-15 |
| Colorimetry, Salicylate | DKJ | Class 2 | Clinical Toxicology | No | 2007-11-15 |
| Enzyme Immunoassay, Procainamide | LAR | Class 2 | Clinical Toxicology | No | 2007-11-15 |
| Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | LBS | Class 1 | Clinical Chemistry | No | 2007-11-15 |
| Photometric Method, Magnesium | JGJ | Class 1 | Clinical Chemistry | No | 2007-11-15 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2007-11-15 |
| System, Test, Low Density, Lipoprotein | MRR | Class 1 | Clinical Chemistry | No | 2007-11-15 |
| Kinetic Method, Gamma-Glutamyl Transpeptidase | JQB | Class 1 | Clinical Chemistry | No | 2007-11-15 |
| Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | CDT | Class 1 | Clinical Chemistry | No | 2007-11-15 |
| Radioimmunoassay, Vancomycin | LEH | Class 2 | Clinical Toxicology | No | 2007-11-15 |
| Catalytic Methods, Amylase | JFJ | Class 2 | Clinical Chemistry | No | 2007-11-15 |
| Colorimetry, Cholinesterase | DIH | Class 1 | Clinical Toxicology | No | 2007-11-15 |
| Fluorescent Immunoassay, Tobramycin | LCR | Class 2 | Clinical Toxicology | No | 2007-11-15 |
| Hexokinase, Glucose | CFR | Class 2 | Clinical Chemistry | No | 2007-11-15 |
| Phosphomolybdate (Colorimetric), Inorganic Phosphorus | CEO | Class 1 | Clinical Chemistry | No | 2007-11-15 |
Proprietary Names
Dimension Vista GGT Flex
Dimension Vista GLU Flex
Dimension Vista SAL Flex
Dimension Vista URCA Flex
Dimension Vista T4 Flex
Dimension Vista CHOL Flex
Dimension Vista LDLC Flex
Dimension Vista LIDO Flex
Dimension Vista AMY Flex
Dimension Vista PHOS Flex
Dimension Vista VALP Flex
Dimension Vista PCHE Flex
Dimension Vista TRIG Flex
Dimension Vista ACTM Flex
Dimension Vista VANC Flex
Dimension Vista TOBR Flex
Dimension Vista PROC Flex
Establishment Types
Manufacture Medical Device