FDA Registration
Active
🇺🇸 United States
VISION DIAGNOSTICS INC.
Reg #: 3011513373
·
FEI: 3011513373
·
Expires 2026
Products
1
Proprietary Names
26
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- VISION DIAGNOSTICS INC.
- Registration Number
- 3011513373
- FEI Number
- 3011513373
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 26689 St. Rd. 247, Suite 200
- City
- Branford
- State
- FL
- ZIP
- 32008
- Country
- US
Owner / Operator
- Firm Name
- Vision Diagnostics Inc
- Operator Number
- 10048906
- Address
- 26689 St. Rd 247, Suite 200
- City
- Branford
- State
- FL
- Postal Code
- 32008
- Country
- US
- Correspondent
- Donna Suggs
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2020-01-30 |
Proprietary Names
Oxidant History Calibrator & Controls (1 ea. 50ml low/hi ctl 1ea. 25ml cal)
Oxidant History Adulterant Det. Reagent 4x50ml 4x20ml 1600 test (AU Series)
True Urine LD Control set
PH Control Kit - low and high 50ml each
Specific Gravity Calibrator Kit (2x25 ml)
Specific Gravity Screening Bulk Reagent Kit 1 Liter (9346 tests)
True Urine LD Reagent 4x50ml 4x20ml 1600 test AU Series
Urine Creatinine Bulk Reagent Kit 1 Liter (5814 tests)
PH Reagent R1(5x 50ml)
PH Screening Bulk Reagent Kit 1 Liter (6670 tests) Beckman AU Series
Urine Creatinine Control / Calibrators
True Urine SD Bulk Reagent Kit 1 Liter (7692 tests)
Urine Creatinine (1600 test) Beckman AU Series
Specific Gravity Screening Reagent 4x50ml 4x20ml 1600 test AU Series
PH Screening Reagent Kit 4x 50ml (1600 tests) Beckman AU Series
True Urine SD Reagent 4x50ml 4x20ml AU Series
True Urine SD Calibrator & Control set
True Urine SD Reagent (Synthetic Urine) R1(4x50ml) R2(1x50ml)
Oxidant History Bulk Reagent Kit 1 Liter (10000) tests
Specific Gravity Control Kit (2x50 ml)
Specific Gravity Index Reagent R1(3x50ml) R2(1x60ml)
Oxidant History Reagent R1(3x60ml) R2(2x45ml)
Urine Creatinine R1(1x50ml) R2(3x92ml)
PH Calibrator Kit 25 ml each Level I 3 & Level II 10.5
True Urine LD Reagent (Synthetic Urine) R1(4x50ml) R2(1x50ml)
True Urine LD Bulk Reagent Kit 1 Liter (8335 tests)
Establishment Types
Manufacture Medical Device