FDA Registration
Active
🇺🇸 United States
ENTEROTRACK
Reg #: 3015545064
·
FEI: 3015545064
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ENTEROTRACK
- Registration Number
- 3015545064
- FEI Number
- 3015545064
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 12635 E. Montview Blvd, Suite 140
- City
- Aurora
- State
- CO
- ZIP
- 80045
- Country
- US
Owner / Operator
- Firm Name
- EnteroTrack
- Operator Number
- 10060542
- Address
- 12635 E. Montview Blvd, Suite 139
- City
- Aurora
- State
- CO
- Postal Code
- 80045
- Country
- US
- Correspondent
- Robin Shandas
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2019-05-23 |
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198