Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005369540

FEI Number

3005369540

Entity Name

MIRAVISTA DIAGNOSTICS

City/State/Country

Indianapolis, IN, US

Establishment Address

4705 Decatur Boulevard, Indianapolis, IN 46241, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

MiraVista Diagnostics (Owner Number: 10077725)

Owner / Operator Contact Address

4705 Decatur Boulevard, Indianapolis, IN 46241, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Histoplasma urine antigen control kit Histoplasma urine antigen LFA test kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MIZ	Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum	Microbiology	Class 2	866.3320	2020-09-15

Official Correspondent

Heather Largura

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MiraVista Diagnostics

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 3005369540. Last updated year: 2026. Please use registration number 3005369540 when referencing this establishment in official correspondence.