FDA Registration
Active
🇺🇸 United States
BioCode Respiratory Pathogen Panel
Reg #: 3007799234
·
FEI: 3007799234
·
Expires 2025
Products
10
Proprietary Names
1
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- Applied BioCode, Inc.
- Registration Number
- 3007799234
- FEI Number
- 3007799234
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 12130 Mora Drive Unit #2
- City
- Santa Fe Springs
- State
- CA
- ZIP
- 90670
- Country
- US
Regulatory Submissions
- 510(k) Number
- K192485
Owner / Operator
- Firm Name
- Applied BioCode, Inc.
- Operator Number
- 10029149
- Address
- 12130 Mora Drive Unit #2, 10370 Slusher Drive Unit #2-7
- City
- Santa Fe Springs
- State
- CA
- Postal Code
- 90670
- Country
- US
- Correspondent
- Raja Krishnamurti
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mycoplasma Pneumoniae Dna Assay System | OZX | Class 2 | Microbiology | No | 2020-01-08 |
| Bordetella Pertussis Dna Assay System | OZZ | Class 2 | Microbiology | No | 2020-01-08 |
| Influenza A Virus Subtype Differentiation Nucleic Acid Assay | OEP | Class 2 | Microbiology | No | 2020-01-08 |
| Instrumentation For Clinical Multiplex Test Systems | NSU | Class 2 | Clinical Chemistry | No | 2020-01-08 |
| Parainfluenza Multiplex Nucleic Acid Assay | OOU | Class 2 | Microbiology | No | 2020-01-08 |
| Human Metapneumovirus (Hmpv) Rna Assay System | OEM | Class 2 | Microbiology | No | 2020-01-08 |
| Influenza A And Influenza B Multiplex Nucleic Acid Assay | OZE | Class 2 | Microbiology | No | 2020-01-08 |
| Non-Sars Coronavirus Multiplex Nucleic Acid Assay | OTG | Class 2 | Microbiology | No | 2020-01-08 |
| Respiratory Virus Panel Nucleic Acid Assay System | OCC | Class 2 | Microbiology | No | 2020-01-08 |
| Chlamydophila Pneumoniae Dna Assay System | OZY | Class 2 | Microbiology | No | 2020-01-08 |
Proprietary Names
BioCode Respiratory Pathogen Panel
Establishment Types
Manufacture Medical Device