FDA Registration
Active
🇺🇸 United States
Healgen
Reg #: 3009238284
·
FEI: 3009238284
·
Expires 2025
Products
12
Proprietary Names
1
Establishment Types
2
Classifications
12
Registration Details
- Registration Name
- HEALGEN SCIENTIFIC LLC
- Registration Number
- 3009238284
- FEI Number
- 3009238284
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3818 Fuqua St
- City
- Houston
- State
- TX
- ZIP
- 77047
- Country
- US
Regulatory Submissions
- 510(k) Number
- K111999
Owner / Operator
- Firm Name
- HEALGEN SCIENTIFIC LLC
- Operator Number
- 10038461
- Address
- 3818 Fuqua Street
- City
- Houston
- State
- TX
- Postal Code
- 77047
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2012-10-10 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2012-10-10 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2012-10-10 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2012-10-10 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2012-10-10 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2012-10-10 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2012-10-10 |
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | Class 1 | Clinical Chemistry | No | 2012-10-10 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2012-10-10 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2012-10-10 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2012-10-10 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2012-10-10 |
Proprietary Names
Healgen
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198