FDA Registration
Active
🇨🇳 China
WUXI NEST BIOTECHNOLOGY CO., LTD
Reg #: 3009302820
·
FEI: 3009302820
·
Expires 2026
Products
12
Proprietary Names
28
Establishment Types
3
Classifications
12
Registration Details
- Registration Name
- WUXI NEST BIOTECHNOLOGY CO., LTD
- Registration Number
- 3009302820
- FEI Number
- 3009302820
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 530, Xida Road, Meicun Industrial Park, Xinwu District
- City
- Wuxi Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K240774
Owner / Operator
- Firm Name
- WUXI NEST BIOTECHNOLOGY CO., LTD
- Operator Number
- 10070331
- Address
- No. 530, Xida Road, Meicun Industrial Park, Xinwu District
- City
- Wuxi
- State
- Jiangsu
- Postal Code
- 214112
- Country
- CN
- Correspondent
- CHENG ZHIWEI
US Agent
- Business Name
- ABMED MEDICAL TECHNOLOGY INC
- Contact Name
- hui hong
- Address
- 800 East Wishkah Street, 1021 Aberdeen,
- City
- Aberdeen
- State
- WA
- ZIP
- 98520
- Country
- US
- [email protected]
- Phone
- 303 8000162
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Culture Media, Non-Selective And Non-Differential | JSG | Class 1 | Microbiology | No | 2020-10-21 |
| Microbial Nucleic Acid Storage And Stabilization Device | QBD | Class 2 | Microbiology | No | 2021-10-15 |
| Nasal Spray, Ent Delivery | KCO | Class 1 | Ear, Nose, Throat | No | 2022-02-09 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2020-04-16 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2020-06-01 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2024-06-21 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2020-05-06 |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | Class 1 | Clinical Chemistry | No | 2020-04-16 |
| Transport Medium, Notified Per The Vtm Guidance | QMC | Class 1 | Microbiology | No | 2021-03-31 |
| Flask, Tissue Culture | KJA | Class 1 | Hematology | No | 2020-04-16 |
| Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | QOF | Class 2 | Microbiology | No | 2026-01-05 |
| Culture Media, Non-Propagating Transport | JSM | Class 1 | Microbiology | No | 2022-05-24 |
Proprietary Names
Disposable Sampler
Disposable Sampler Inactivated Transport Media
Disposable Intranasal Atomization Device
PCR tube
Syringe filter
pipette tips
cryopreservation tube
Pasteur pipette
sample vials
centrifuge tube
microcentrifuge tube
Saliva collection kit
Pen Injector
Oropharyngeal Specimen Collection Swab Cat.No.:202003
Nasopharyngeal Swabs
Specimen Collection Swab
Nasopharyngeal Specimen Collection Swab Cat.No.:202004
centrifuge; general laboratory instrument
Disposable Sampler Viral Transport Media
cell culture flask
Elisa plate
deep well plate
dish
storage bottle
PCR plate
cell culture plate
NES Sample Vial
Disposable Pen Injector Assembly
Establishment Types
Manufacture Medical Device
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device for Another Party (Contract Manufacturer)