FDA Registration
Active
🇺🇸 United States
PyloPlus Urea Breath Test
Reg #: 3004577174
·
FEI: 3004577174
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ARJ MEDICAL, LLC. / Gulf Coast Scientific, LLC.
- Registration Number
- 3004577174
- FEI Number
- 3004577174
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 209 State St E
- City
- OLDSMAR
- State
- FL
- ZIP
- 34677
- Country
- US
Regulatory Submissions
- PMA Number
- P170022
Owner / Operator
- Firm Name
- ARJ MEDICAL, INC.
- Operator Number
- 9078060
- Address
- 209 STATE STREET EAST, --
- City
- Oldsmar
- State
- FL
- Postal Code
- 34677
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Urea Adult And Pediatric (Breath), | OZA | Class 3 | Microbiology | No | 2020-03-03 |
Proprietary Names
PyloPlus Urea Breath Test
PyloPlus UBT System
PyloPlus 13C Urea Breath Test
Establishment Types
Manufacture Medical Device