FDA Registration
Active
🇦🇷 Argentina
Urine Strip
Reg #: 8040374
·
FEI: 5864
·
Expires 2025
Products
11
Proprietary Names
1
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- WIENER LABORATORIOS S.A.I.C.
- Registration Number
- 8040374
- FEI Number
- 5864
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2571 Maipu
- City
- ROSARIO Santa Fe
- Country
- AR
Regulatory Submissions
- 510(k) Number
- K083724
Owner / Operator
- Firm Name
- WIENER LABORATORIOS S.A.I.C.
- Operator Number
- 8040374
- Address
- RioBamba 2944
- City
- Rosario
- State
- AR-NOTA
- Postal Code
- 2000
- Country
- AR
US Agent
- Business Name
- REGISTRAR CORP
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- HAMPTON
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2010-11-30 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2010-11-30 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2010-11-30 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2010-11-30 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2010-11-30 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2010-11-30 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2010-11-30 |
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | Class 1 | Clinical Chemistry | No | 2010-11-30 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2010-11-30 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2010-11-30 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2010-11-30 |
Proprietary Names
Urine Strip
Establishment Types
Manufacture Medical Device