FDA Registration
Active
🇨🇳 China
ePlex® Respiratory Pathogen (RP) Panel
Reg #: 3013019728
·
FEI: 3013019728
·
Expires 2025
Products
10
Proprietary Names
1
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- Hochuen Medical Technology Co.,Ltd.
- Registration Number
- 3013019728
- FEI Number
- 3013019728
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building 2,ChungKin lnd.Estate,Huaxing Road,Dalang,Longhua District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K163636
Owner / Operator
- Firm Name
- Hochuen Medical Technology Co.,Ltd.
- Operator Number
- 10055509
- Address
- Building 2,ChungKin lnd.Estate,Huaxing Road,Dalang,Longhua District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518109
- Country
- CN
US Agent
- Business Name
- MEDRIGHT TECH INC
- Contact Name
- Jessie Yao
- Address
- 6302 FORT HAMILTON PARKWAY, 1R
- City
- Brooklyn
- State
- NY
- ZIP
- 11219
- Country
- US
- [email protected]
- Phone
- 718 2169957
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Human Metapneumovirus (Hmpv) Rna Assay System | OEM | Class 2 | Microbiology | No | 2017-12-18 |
| Influenza A And Influenza B Multiplex Nucleic Acid Assay | OZE | Class 2 | Microbiology | No | 2017-12-18 |
| Non-Sars Coronavirus Multiplex Nucleic Acid Assay | OTG | Class 2 | Microbiology | No | 2017-12-18 |
| Influenza A Virus Subtype Differentiation Nucleic Acid Assay | OEP | Class 2 | Microbiology | No | 2017-12-18 |
| Respiratory Virus Panel Nucleic Acid Assay System | OCC | Class 2 | Microbiology | No | 2017-12-18 |
| Chlamydophila Pneumoniae Dna Assay System | OZY | Class 2 | Microbiology | No | 2017-12-18 |
| Parainfluenza Multiplex Nucleic Acid Assay | OOU | Class 2 | Microbiology | No | 2017-12-18 |
| Mycoplasma Pneumoniae Dna Assay System | OZX | Class 2 | Microbiology | No | 2017-12-18 |
| Instrumentation For Clinical Multiplex Test Systems | NSU | Class 2 | Clinical Chemistry | No | 2017-12-18 |
| 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification | OQW | Class 2 | Microbiology | No | 2017-12-18 |
Proprietary Names
ePlex® Respiratory Pathogen (RP) Panel
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)