Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1050138

FEI Number

1050138

Entity Name

Microbiologics, Inc.

City/State/Country

LEXINGTON, KY, US

Establishment Address

1040 Manchester St, LEXINGTON, KY 40508, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Microbiologics, Inc. (Owner Number: 10091576)

Owner / Operator Contact Address

200 Cooper Avenue North, Saint Cloud, MN 56303, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TVS-01 Tri-Valent Positive Control Swab VV-01 Vaginitis Validation Panel VP-03 Trichomonas Verification Set TVS-02 Tri-Valent Negative Control Swab 100111 India Ink, Positive Control 100112 India Ink, Negative Control 100114 India Ink 100115 India Ink Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	Class 1	862.1660	2024-10-16
JTS	Stains, Microbiologic	Hematology	Class 1	864.1850	2024-10-18

Official Correspondent

Tina Sobania

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Microbiologics, Inc.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0025-05	Becton Dickinson & Co.	1	Difco (TM) BBL (TM) Gram Crystal Violet, 250 mL bottles in packs of four, catalog # 212525 and 3.8 L bottles, catalog # 212526, staining reagent.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1050138. Last updated year: 2026. Please use registration number 1050138 when referencing this establishment in official correspondence.