FDA Registration
Active
🇺🇸 United States
DIAGNOSTICS FOR THE REAL WORLD, LTD.
Reg #: 3006247421
·
FEI: 3006247421
·
Expires 2026
Products
4
Proprietary Names
8
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- DIAGNOSTICS FOR THE REAL WORLD, LTD.
- Registration Number
- 3006247421
- FEI Number
- 3006247421
- Status
- Active
- Expiry Year
- 2026
- 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 |
|---|---|---|---|---|---|
| Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | QOF | Class 2 | Microbiology | No | 2022-12-23 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2012-11-02 |
| Monitor,Test,Hiv-1 | MTL | Class 3 | Unknown | No | 2020-09-15 |
| Respiratory Specimen Nucleic Acid Sars-Cov-2 Test | QQX | Class 2 | Microbiology | No | 2022-12-23 |
Proprietary Names
SAMBA II SARS-CoV-2/FluA/FluB Test
SAMBA II SARS-CoV-2/RSV Test
FirstBurst Urine Collection Device
SAMBA II HIV-1 Semi-Q Test
SAMBA II HIV-1 Qual Whole Blood Test
SAMBA HIV-1 Semi-Q Test
SAMBA I HIV-1 Qual Whole Blood Test
SAMBA II SARS-CoV-2 Test
Establishment Types
Manufacture Device in the United States for Export Only
Manufacture Medical Device