Product Code: GMZ FDA class 1 21 CFR 866.3255

Antigens, All Types, Escherichia Coli

Microbiology

The Antigens for All Types of Escherichia Coli are serotyping reagents used in microbiology laboratories to characterize E. coli strains through antigen-based methods, aiding in the epidemiological investigation of infections and outbreaks. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls without a premarket submission requirement. The product code is GMZ, regulated under 21 CFR 866.3255 in the Microbiology specialty.

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Basic Information

Product Code: GMZ
Device Class: FDA class 1
Regulation Number: 866.3255
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 14 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K222829	Curian® Shiga Toxin	Apr 17, 2023	Substantially Equivalent	Meridian Bioscience, Inc.
K121411	SHIGA TOXIN CHEK	Oct 02, 2012	Substantially Equivalent	Techlab Inc., Corporate Research Center
K121364	SHIGA TOXIN QUIK CHEK	Oct 02, 2012	Substantially Equivalent	Techlab Inc., Corporate Research Center
K062546	IMMUNOCARD STAT! EHEC, MODEL 751630	Feb 14, 2007	Substantially Equivalent	Meridian Bioscience, Inc.
K061889	BIOSTAR OIA SHIGATOX	Dec 12, 2006	Substantially Equivalent	Inverness Medical-Biostar, Inc.
K023599	IMMUNOCARD STAT! E. COLI O157 PLUS	Jan 03, 2003	Substantially Equivalent	Meridian Bioscience, Inc.
K990263	IMMUNOCARD STAT! E. COLI O157:H7	Aug 09, 1999	Substantially Equivalent	Meridian Diagnostics, Inc.
K980507	PROSPECT SHIGA TOXIN MICROPLATE ASSAY	Apr 23, 1998	Substantially Equivalent	Alexon - Trend, Inc.
K973457	CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800	Jan 02, 1998	Substantially Equivalent	Shared Systems, Inc.
K971663	WELLCOLEX E.COLI O157:H7	Dec 30, 1997	Substantially Equivalent	Murex Biotech , Ltd.
K972156	QUIX RAPID E. COLI O157 STRIP TEST	Oct 16, 1997	Substantially Equivalent	Guardian Scientific, Corp.
K942705	E. COLI 0157 ELISA STOOL ASSAY	Sep 27, 1995	Substantially Equivalent	Lmd Laboratories
K944421	E.COLI 0157 LATEX TEST	Dec 15, 1994	Substantially Equivalent	Pro-Lab Diagnostics
K884513	PF TEST	Feb 03, 1989	Substantially Equivalent	Medi-Tech, Inc.