FDA Registration
Active
🇺🇸 United States
JJX GlucoVitaal HbA1c Control
Reg #: 1220649
·
FEI: 1220649
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- BIONOSTICS, INC.
- Registration Number
- 1220649
- FEI Number
- 1220649
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7 JACKSON RD.
- City
- Devens
- State
- MA
- ZIP
- 01434
- Country
- US
Regulatory Submissions
- 510(k) Number
- K141829
Owner / Operator
- Firm Name
- BIONOSTICS, INC.
- Operator Number
- 1220649
- Address
- 7 JACKSON RD., --
- City
- Devens
- State
- MA
- Postal Code
- 01434
- Country
- US
- Correspondent
- Yifei Wang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2015-01-05 |
| Glucose Dehydrogenase, Glucose | LFR | Class 2 | Clinical Chemistry | No | 2015-01-05 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2015-01-05 |
Proprietary Names
JJX GlucoVitaal HbA1c Control
Establishment Types
Manufacture Medical Device