FDA Registration
Active
🇺🇸 United States
T2Candida 1.1 Panel
Reg #: 3010097867
·
FEI: 3010097867
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- T2 BIOSYSTEMS, INC.
- Registration Number
- 3010097867
- FEI Number
- 3010097867
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 101 Hartwell Ave
- City
- Lexington
- State
- MA
- ZIP
- 02421
- Country
- US
Regulatory Submissions
- 510(k) Number
- K173536
Owner / Operator
- Firm Name
- T2 Biosystems, Inc.
- Operator Number
- 10049038
- Address
- 101 Hartwell Avenue
- City
- Lexington
- State
- MA
- Postal Code
- 02421
- Country
- US
- Correspondent
- Scott Blood
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Candida Species Nucleic Acid Detection System | PII | Class 2 | Microbiology | No | 2018-06-22 |
Proprietary Names
T2Candida 1.1 Panel
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device