FDA Registration
Active
🇺🇸 United States
BioPlex 2200 Syphilis Total & RPR Calibrator
Reg #: 3032705
·
FEI: 3002701146
·
Expires 2025
Products
4
Proprietary Names
3
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- BIO-RAD LABORATORIES, INC.
- Registration Number
- 3032705
- FEI Number
- 3002701146
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 14620 NE North Woodinville Way
- City
- Woodinville
- State
- WA
- ZIP
- 98072
- Country
- US
Regulatory Submissions
- 510(k) Number
- K170413
Owner / Operator
- Firm Name
- BIO-RAD LABORATORIES, INC.
- Operator Number
- 3022521
- Address
- 8415 216th St SE, --
- City
- Woodinville
- State
- WA
- Postal Code
- 98072
- Country
- US
- Correspondent
- David - Bhend
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | LIP | Class 2 | Microbiology | No | 2017-05-24 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2017-05-24 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2017-05-24 |
| Antigens, Nontreponemal, All | GMQ | Class 2 | Microbiology | No | 2017-05-24 |
Proprietary Names
BioPlex 2200 Syphilis Total & RPR Calibrator
BioPlex 2200 Syphilis Total and RPR
BioPlex 2200 Syphilis Total & RPR Control
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)