FDA Registration
Active
🇺🇸 United States
BioPlex 2200 Syphilis Total & RPR
Reg #: 2915274
·
FEI: 2915274
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- Bio-Rad Laboratories, Inc.
- Registration Number
- 2915274
- FEI Number
- 2915274
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 4000 Alfred Nobel Drive
- City
- Hercules
- State
- CA
- ZIP
- 94547
- Country
- US
Regulatory Submissions
- 510(k) Number
- K170413
Owner / Operator
- Firm Name
- Bio-Rad Laboratories, Inc.
- Operator Number
- 9929003
- Address
- 4000 Alfred Nobel Drive, --
- City
- Hercules
- State
- CA
- Postal Code
- 94547
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | LIP | Class 2 | Microbiology | No | 2017-05-25 |
| Antigens, Nontreponemal, All | GMQ | Class 2 | Microbiology | No | 2017-05-25 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2017-05-25 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2017-05-25 |
Proprietary Names
BioPlex 2200 Syphilis Total & RPR
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility