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GMZ — Antigens, All Types, Escherichia Coli Class I

FDA Device Classification

Classification Details

Product Code
GMZ
Device Class
Class I
Regulation Number
866.3255
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K222829meridian bioscienceCurian® Shiga ToxinApril 17, 2023
K121411techlab inc., corporate research centerSHIGA TOXIN CHEKOctober 2, 2012
K121364techlab inc., corporate research centerSHIGA TOXIN QUIK CHEKOctober 2, 2012
K062546meridian bioscienceIMMUNOCARD STAT! EHEC, MODEL 751630February 14, 2007
K061889inverness medical-biostarBIOSTAR OIA SHIGATOXDecember 12, 2006
K023599meridian bioscienceIMMUNOCARD STAT! E. COLI O157 PLUSJanuary 3, 2003
K990263meridian diagnosticsIMMUNOCARD STAT! E. COLI O157:H7August 9, 1999
K980507alexon - trendPROSPECT SHIGA TOXIN MICROPLATE ASSAYApril 23, 1998
K973457shared systemsCHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800January 2, 1998
K971663murex biotechWELLCOLEX E.COLI O157:H7December 30, 1997
K972156guardian scientificQUIX RAPID E. COLI O157 STRIP TESTOctober 16, 1997
K942705lmd laboratoriesE. COLI 0157 ELISA STOOL ASSAYSeptember 27, 1995
K944421pro-lab diagnosticsE.COLI 0157 LATEX TESTDecember 15, 1994
K884513medi-techPF TESTFebruary 3, 1989