FDA Registration
Active
🇺🇸 United States
SAMBA I HIV-1 Qual Whole Blood Test
Reg #: 3006247421
·
FEI: 3006247421
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DIAGNOSTICS FOR THE REAL WORLD, LTD.
- Registration Number
- 3006247421
- FEI Number
- 3006247421
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 220 Vineyard Ct Ste 150
- City
- Morgan Hill
- State
- CA
- ZIP
- 95037
- Country
- US
Owner / Operator
- Firm Name
- DIAGNOSTICS FOR THE REAL WORLD, LTD.
- Operator Number
- 9100726
- Address
- 220 Vineyard Court Ste 150
- City
- Morgan Hill
- State
- CA
- Postal Code
- 95037
- Country
- US
- Correspondent
- Lourdes M Nadala
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor,Test,Hiv-1 | MTL | Class 3 | Unknown | No | 2020-09-15 |
Proprietary Names
SAMBA I HIV-1 Qual Whole Blood Test
SAMBA II HIV-1 Qual Whole Blood Test
SAMBA HIV-1 Semi-Q Test
SAMBA II HIV-1 Semi-Q Test
Establishment Types
Manufacture Device in the United States for Export Only