FDA Registration
Active
🇺🇸 United States
LABTURBO BIOTECH, LLC
Reg #: 3016611336
·
FEI: 3016611336
·
Expires 2026
Products
4
Proprietary Names
14
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- LABTURBO BIOTECH, LLC
- Registration Number
- 3016611336
- FEI Number
- 3016611336
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 12 Roszel Road, B102
- City
- Princeton
- State
- NJ
- ZIP
- 08540
- Country
- US
Owner / Operator
- Firm Name
- LabTurbo Biotech, LLC
- Operator Number
- 10082497
- Address
- 12 Roszel Rd.
- City
- Princeton
- State
- NJ
- Postal Code
- 08540
- Country
- US
- Correspondent
- Yi-Fan Lin
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Station, Pipetting And Diluting, For Clinical Use | JQW | Class 1 | Clinical Chemistry | No | 2024-06-03 |
| Clinical Sample Concentrator | JJH | Class 1 | Clinical Chemistry | No | 2024-06-03 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2024-06-03 |
| Instrumentation For Clinical Multiplex Test Systems | NSU | Class 2 | Clinical Chemistry | No | 2024-06-03 |
Proprietary Names
LabTurbo 45 Compact System
LabTurbo 24 Compact System
LabTurbo 96 Compact System
LabTurbo 48 Compact System
LabTurbo Reaction (PCR) Setup System
LabTurbo DNA Mini Kit
LabTurbo DNA AIO kit
LabTurbo Viral DNA/RNA Mini Kit
LabTurbo Forensic DNA Mini Kit
LabTurbo viral DNA/RNA AIO kit
LabTurbo Stool DNA/RNA mini kit
LabTurbo Specimen Collection Kit
LabTurbo AIO 24 SP-qPCR Automation System
LabTurbo AIO 48 SP-qPCR Automation System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device