FDA Registration
Active
🇹🇼 Taiwan
Quantitative Cartridge Kit; Quantitative marker; Alignment Marker; Size Marker; Separation Buffer; Dilution Buffer; Mineral Oil;
Reg #: 3010030414
·
FEI: 3010030414
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BIOPTIC INC.
- Registration Number
- 3010030414
- FEI Number
- 3010030414
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4F., No.108-3 & No. 108-4,Minquan Rd., Xindian Dist.
- City
- New Taipei
- Country
- TW
Owner / Operator
- Firm Name
- BiOptic Inc.
- Operator Number
- 10086887
- Address
- 4F., No.108-3 & No. 108-4,Minquan Rd., Xindian Dist.
- City
- New Taipei
- State
- TW-NWT
- Postal Code
- 23141
- Country
- TW
- Correspondent
- Yutien Huang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Apparatus, Electrophoresis, For Clinical Use | JJN | Class 1 | Clinical Chemistry | No | 2022-12-20 |
Proprietary Names
Quantitative Cartridge Kit; Quantitative marker; Alignment Marker; Size Marker; Separation Buffer; Dilution Buffer; Mineral Oil;
Power Supply; Air Pump; Purge Station
DNA Cartridges (S1, S2, S3, F3, N1, N3, L1, L2, L3); RNA Cartridges (R1, NR1, LR1); Protein Cartridges (P2);
Qsep Series Bio-Fragment Analyzer (Qsep1, Qsep1-Lite, Qsep1-Plus; Qsep100, Qsep100 Advance; Qsep400; Qsep400 SE; Qsep400 Advance; QsepUltra);
Establishment Types
Manufacture Medical Device