FDA Registration
Active
🇺🇸 United States
VERICHEM LABORATORIES, INC.
Reg #: 1221645
·
FEI: 1221645
·
Expires 2026
Products
5
Proprietary Names
21
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- VERICHEM LABORATORIES, INC.
- Registration Number
- 1221645
- FEI Number
- 1221645
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 90 NARRAGANSETT AVE.
- City
- Providence
- State
- RI
- ZIP
- 02907
- Country
- US
Regulatory Submissions
- 510(k) Number
- K112834
Owner / Operator
- Firm Name
- VERICHEM LABORATORIES, INC.
- Operator Number
- 1221645
- Address
- 90 NARRAGANSETT AVE., --
- City
- Providence
- State
- RI
- Postal Code
- 02907
- Country
- US
- Correspondent
- ANTHONY J DIMONTE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2012-12-28 |
| Calibrator, Primary | JIS | Class 2 | Clinical Chemistry | No | 2007-12-28 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2007-12-28 |
| Calibrators, Ethyl Alcohol | DNN | Class 2 | Clinical Toxicology | No | 2011-01-10 |
| Enzyme Controls (Assayed And Unassayed) | JJT | Class 1 | Clinical Chemistry | No | 2007-12-28 |
Proprietary Names
Urine Chemistry Standard Kit
Electrolyte Standard Kit
Carbon Dioxide Standard Kit, Level (F)
Carbon Dioxide Standard Kit
Carbon Dioxide Standard, 30 mmol/L
HDL Cholesterol Verifier Kit
Bilirubin Standard Kit
Bilirubin Standard Level (F)
BR2 Bilirubin Calibrator
Total Protein/Albumin Level (F)
Total Protein/Albumin Standard Kit
Ethanol Standard Kit
Ammonia/Iron Standard, Level (F)
Ammonia/Iron Standard Kit
Matrix Plus Chemistry Level (F)
Matrix Plus Cholesterol Level (F)
Matrix Plus Cholesterol Reference
Matrix Plus Chemistry Reference Kit
Microprotein Standard Kit
Enzyme ER Verifier Kit
Enzyme PLUS Verifier Kit
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device