FDA Registration
Active
🇺🇸 United States
Syva RapidTest d.a.u. 10 mAMP/OPI/COC/THC/PCP/BZO/BAR/MDN/TCA/AMP
Reg #: 2517506
·
FEI: 2517506
·
Expires 2025
Products
10
Proprietary Names
1
Establishment Types
1
Classifications
10
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
- K990786
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 |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2017-09-05 |
| Radioimmunoassay, Barbiturate | DKN | Class 2 | Clinical Toxicology | No | 2017-09-05 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2017-09-05 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2017-09-05 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2017-09-05 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2017-09-05 |
| High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs | LFI | Class 2 | Clinical Toxicology | No | 2017-09-05 |
| High Pressure Liquid Chromatography, Methamphetamine | LAG | Class 2 | Clinical Toxicology | No | 2017-09-05 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2017-09-05 |
| Reagents, Test, Tetrahydrocannabinol | DKE | Class 2 | Clinical Toxicology | No | 2017-09-05 |
Proprietary Names
Syva RapidTest d.a.u. 10 mAMP/OPI/COC/THC/PCP/BZO/BAR/MDN/TCA/AMP
Establishment Types
Manufacture Medical Device