FDA Registration
Active
🇺🇸 United States
Alius Scientific,LLC
Reg #: 3010324880
·
FEI: 3010324880
·
Expires 2025
Products
6
Proprietary Names
0
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- Alius Scientific,LLC
- Registration Number
- 3010324880
- FEI Number
- 3010324880
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- CALLE 246 PB54, COUNTRY CLUB
- City
- Carolina
- State
- PR
- ZIP
- 00982
- Country
- US
Regulatory Submissions
- 510(k) Number
- K133519
Owner / Operator
- Firm Name
- Alius Scientific, LLC
- Operator Number
- 10072559
- Address
- Via Pedregal #10, Montecillo Court #3208
- City
- Trujillo Alto
- State
- PR
- Postal Code
- 00976
- Country
- US
- Correspondent
- Richard Mangual
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2021-07-22 |
| Hexokinase, Glucose | CFR | Class 2 | Clinical Chemistry | No | 2021-07-22 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2021-07-22 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2021-07-22 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2021-07-22 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2021-07-22 |
Establishment Types
Complaint File Establishment per 21 CFR 820.198