FDA Registration
Active
🇺🇸 United States
MOL2150 Simplexa HSV 1 & 2 Direct MOL2160 Simplexa HSV 1 & 2 Positive Control Pack
Reg #: 2023365
·
FEI: 2023365
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DiaSorin Molecular LLC
- Registration Number
- 2023365
- FEI Number
- 2023365
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 11331 Valley View St
- City
- CYPRESS
- State
- CA
- ZIP
- 90630
- Country
- US
Regulatory Submissions
- 510(k) Number
- K150962
Owner / Operator
- Firm Name
- DiaSorin Molecular LLC
- Operator Number
- 9089763
- Address
- 11331 Valley View Street, --
- City
- Cypress
- State
- CA
- Postal Code
- 90630
- Country
- US
- Correspondent
- Mari Meyer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Herpes Simplex Virus Nucleic Acid Amplification Assay | OQO | Class 2 | Microbiology | No | 2015-09-02 |
Proprietary Names
MOL2150 Simplexa HSV 1 & 2 Direct MOL2160 Simplexa HSV 1 & 2 Positive Control Pack
Establishment Types
Manufacture Medical Device