FDA Registration
Active
🇺🇸 United States
JIS / Calibrator, primary LCP / ASSAY, GLYCOSYLATED HEMOGLOBIN JJX / Single (specified) analyte controls (assayed and unassayed)
Reg #: 3015550354
·
FEI: 3015550354
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- MONOCENT INC.
- Registration Number
- 3015550354
- FEI Number
- 3015550354
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 8920 Quartz Ave
- City
- Northridge
- State
- CA
- ZIP
- 91324
- Country
- US
Regulatory Submissions
- 510(k) Number
- K051200
Owner / Operator
- Firm Name
- Monocent Inc.
- Operator Number
- 10060554
- Address
- 8920 Quartz Ave
- City
- Northridge
- State
- CA
- Postal Code
- 91324
- Country
- US
- Correspondent
- Shervin Taheri
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Assay, Glycosylated Hemoglobin | LCP | Class 2 | Hematology | No | 2023-01-06 |
| Calibrator, Primary | JIS | Class 2 | Clinical Chemistry | No | 2023-01-06 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2023-01-06 |
Proprietary Names
JIS / Calibrator, primary LCP / ASSAY, GLYCOSYLATED HEMOGLOBIN JJX / Single (specified) analyte controls (assayed and unassayed)
Establishment Types
Manufacture Medical Device