FDA Registration
Active
🇹🇼 Taiwan
assaya iaX-2101
Reg #: 3017877290
·
FEI: 3017877290
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- APOLLO BIOTECH CO., LTD.
- Registration Number
- 3017877290
- FEI Number
- 3017877290
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 18F-1 No. 75 Xintai 5th Road, Xizhi 22101
- City
- New Taipei City
- Country
- TW
Owner / Operator
- Firm Name
- Apollo BioTech co., ltd.
- Operator Number
- 10082148
- Address
- 18F-1 No. 75 Xintai 5th Road, Xizhi 22101
- City
- New Taipei City
- State
- TW-NWT
- Postal Code
- 22101
- Country
- TW
- Correspondent
- Abri-Elle Sivertsen
US Agent
- Business Name
- Assaya LLC
- Contact Name
- Abri-Elle Sivertsen
- Address
- 641 W Johns Rd NW
- City
- Lilburn
- State
- GA
- ZIP
- 30047
- Country
- US
- [email protected]
- Phone
- 678 2341775
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | Class 1 | Clinical Chemistry | No | 2021-06-20 |
Proprietary Names
assaya iaX-2101
Apollo BioTech iaX-2101
assaya intelligent analyzer eXpress-2101
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility