FDA Registration
Active
🇹🇼 Taiwan
LV Module (30/100 sets); 1mm Beads Tube (36/50/250 pcs); 3mm Beads Tube (36/50/250 pcs)
Reg #: 3010030414
·
FEI: 3010030414
·
Expires 2025
Products
1
Proprietary Names
3
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 |
|---|---|---|---|---|---|
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2023-02-16 |
Proprietary Names
LV Module (30/100 sets); 1mm Beads Tube (36/50/250 pcs); 3mm Beads Tube (36/50/250 pcs)
Elution Tube (36/50 pcs); EtOH Tube (36/50 pcs); Sample Tube (36/50 pcs); Syringe (36/50 pcs); Tip Set (36/50 pcs)
Micro Vial; Sample tray; Buffer tray; Droppers; PCR tubes; 16+3-well Sample Tube; Rotor plate (for 16+3 tube)
Establishment Types
Manufacture Medical Device