Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011513373

FEI Number

3011513373

Entity Name

VISION DIAGNOSTICS INC.

City/State/Country

Branford, FL, US

Establishment Address

26689 St. Rd. 247, Suite 200, Branford, FL 32008, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Vision Diagnostics Inc (Owner Number: 10048906)

Owner / Operator Contact Address

26689 St. Rd 247, Suite 200, Branford, FL 32008, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2020-01-30

Official Correspondent

Donna Suggs

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Vision Diagnostics Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011513373. Last updated year: 2026. Please use registration number 3011513373 when referencing this establishment in official correspondence.