FDA Registration
Active
🇺🇸 United States
Alius Scientific,LLC
Reg #: 3010324880
·
FEI: 3010324880
·
Expires 2025
Products
12
Proprietary Names
0
Establishment Types
1
Classifications
12
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
- K040703
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 |
|---|---|---|---|---|---|
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2021-07-22 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2021-07-22 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2021-07-22 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2021-07-22 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2021-07-22 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | Class 1 | Clinical Chemistry | No | 2021-07-22 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2021-07-22 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2021-07-22 |
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | Class 1 | Clinical Chemistry | No | 2021-07-22 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2021-07-22 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2021-07-22 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2021-07-22 |
Establishment Types
Complaint File Establishment per 21 CFR 820.198