FDA Registration
Active
🇺🇸 United States
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
Reg #: 3008632402
·
FEI: 3008632402
·
Expires 2025
Products
3
Proprietary Names
2
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- GENMARK DIAGNOSTICS, INC.
- Registration Number
- 3008632402
- FEI Number
- 3008632402
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- GenMark Diagnostics, Inc., 5964 La Place Ct
- City
- Carlsbad
- State
- CA
- ZIP
- 92008
- Country
- US
Regulatory Submissions
- 510(k) Number
- K182619
Owner / Operator
- Firm Name
- GenMark Diagnostics, Inc.
- Operator Number
- 9056858
- Address
- GenMark Diagnostics, Inc., 5964 La Place Ct
- City
- Carlsbad
- State
- CA
- Postal Code
- 92008
- Country
- US
- Correspondent
- Alan B Maderazo
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fungal Organisms, Nucleic Acid-Based Assay | PEO | Class 2 | Microbiology | No | 2019-05-30 |
| Gram-Positive Bacteria And Their Resistance Markers | PAM | Class 2 | Microbiology | No | 2019-05-30 |
| Gram-Negative Bacteria And Associated Resistance Markers | PEN | Class 2 | Microbiology | No | 2019-05-30 |
Proprietary Names
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
cobas® eplex blood culture identification gram negative (BCID-GN) panel
Establishment Types
Manufacture Medical Device