FDA Registration
Active
🇺🇸 United States
Pheno
Reg #: 3010671651
·
FEI: 3010671651
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- ACCELERATE DIAGNOSTICS, INC.
- Registration Number
- 3010671651
- FEI Number
- 3010671651
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3950 S COUNTRY CLUB RD STE 470
- City
- Tucson
- State
- AZ
- ZIP
- 85714
- Country
- US
Regulatory Submissions
- 510(k) Number
- K192665
Owner / Operator
- Firm Name
- Accelerate Diagnostics Inc.,
- Operator Number
- 10054275
- Address
- 3950 S. Country Club Road, Suite 470
- City
- Tucson
- State
- AZ
- Postal Code
- 85714
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | LON | Class 2 | Microbiology | No | 2022-04-13 |
| Instrumentation For Clinical Multiplex Test Systems | NSU | Class 2 | Clinical Chemistry | No | 2022-04-13 |
| Fungal Organisms, Nucleic Acid-Based Assay | PEO | Class 2 | Microbiology | No | 2022-04-13 |
| Positive Blood Culture Identification And Ast Kit | PRH | Class 2 | Microbiology | No | 2022-04-13 |
| Gram-Positive Bacteria And Their Resistance Markers | PAM | Class 2 | Microbiology | No | 2022-04-13 |
| Gram-Negative Bacteria And Associated Resistance Markers | PEN | Class 2 | Microbiology | No | 2022-04-13 |
Proprietary Names
Pheno
Establishment Types
Manufacture Medical Device