FDA Registration
Active
🇺🇸 United States
EL0950 HSV Serum Panel
Reg #: 2023365
·
FEI: 2023365
·
Expires 2025
Products
1
Proprietary Names
13
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
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 |
|---|---|---|---|---|---|
| Multi-Analyte Controls Unassayed | OHQ | Class 1 | Clinical Chemistry | No | 2009-12-16 |
Proprietary Names
EL0950 HSV Serum Panel
EL1823 Anti-Natalizumab Control 1
EL1824 Anti-Natalizumab Control 2
IF1410 Anaplasma phagocytophilum IFA IgG Detectable Control
EL1825 Normal Human Serum
IF1412 Anaplasma phagocytophilum IFA IgM Detectable Control
IF1012 Ehrlichia chaffeensis IFA IgM Detectable Control
IF1011 Ehrlichia chaffeensis IFA Non-Detectable Control
IF1313 Bartonella IFA Non- Detectable Control
IF1411 Anaplasma phagocytophilum IFA Non- Detectable Control
IF1010 Ehrlichia chaffeensis IFA IgG Detectable Control
IF1314 Bartonella IFA Polyvalent Detectable Control
IF0910 Babesia microti IFA IgG Detectable Control
Establishment Types
Manufacture Medical Device