Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2150138

FEI Number

2150138

Entity Name

MICROBIOLOGICS, INC.

City/State/Country

Saint Cloud, MN, US

Establishment Address

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

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MICROBIOLOGICS, INC. (Owner Number: 2150138)

Owner / Operator Contact Address

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

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191172

PMA Number

N/A

All Registered Proprietary Names

100111 India Ink, Positive Control 100114 India Ink 100112 India Ink, Negative Control 100115 India Ink Kit BD MAX Enteric Parasite Control Panel BD MAX Enteric Parasite 20-Day QC Panel Microbiology QC Slides HE0082HF GI Hydration Fluid Assayed CT/NG Control Panel Parasite Suspensions Assayed C. difficile/Epi Control Panel Assayed MRSA NxG Control Panel

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JTS	Stains, Microbiologic	Hematology	Class 1	864.1850	2020-10-26
PMN	Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays	Microbiology	Class 2	866.3920	2018-08-22
LJG	Quality Control Slides	Microbiology	Class 1	866.2660	2005-02-04
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2026-01-21
PMN	Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays	Microbiology	Class 2	866.3920	2019-05-14
LIB	Device, General Purpose, Microbiology, Diagnostic	Microbiology	Class 1	866.2660	2005-02-04
PMN	Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays	Microbiology	Class 2	866.3920	2019-04-30
PMN	Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays	Microbiology	Class 2	866.3920	2019-07-17

Official Correspondent

No official correspondent registered.

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 →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014673819	SENSID GMBH	Rostock Mecklenburg-Western Pomerania, DE

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 2150138. Last updated year: 2026. Please use registration number 2150138 when referencing this establishment in official correspondence.