Product code GMZ— Microbiology

FDA has cleared 14 devices under product code GMZ between 1989 and 2023, filed by 11 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 20231 clearance
• 20122 clearances
• 20071 clearance
• 20061 clearance
• 20031 clearance
• 19991 clearance
• 19982 clearances
• 19972 clearances
• 19951 clearance
• 19941 clearance
• 19891 clearance

• Meridian Bioscience, Inc.3 clearances
• Techlab Inc., Corporate Research Center2 clearances
• Shared Systems, Inc.1 clearance
• Pro-Lab Diagnostics1 clearance
• Murex Biotech , Ltd.1 clearance
• Meridian Diagnostics, Inc.1 clearance
• Medi-Tech, Inc.1 clearance
• Lmd Laboratories1 clearance
• Inverness Medical-Biostar, Inc.1 clearance
• Guardian Scientific, Corp.1 clearance

• K222829 — Curian® Shiga ToxinMeridian Bioscience, Inc.·2023-04-17
• K121364 — SHIGA TOXIN QUIK CHEKTechlab Inc., Corporate Research Center·2012-10-02
• K121411 — SHIGA TOXIN CHEKTechlab Inc., Corporate Research Center·2012-10-02
• K062546 — IMMUNOCARD STAT! EHEC, MODEL 751630Meridian Bioscience, Inc.·2007-02-14
• K061889 — BIOSTAR OIA SHIGATOXInverness Medical-Biostar, Inc.·2006-12-12
• K023599 — IMMUNOCARD STAT! E. COLI O157 PLUSMeridian Bioscience, Inc.·2003-01-03
• K990263 — IMMUNOCARD STAT! E. COLI O157:H7Meridian Diagnostics, Inc.·1999-08-09
• K980507 — PROSPECT SHIGA TOXIN MICROPLATE ASSAYAlexon - Trend, Inc.·1998-04-23
• K973457 — CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800Shared Systems, Inc.·1998-01-02
• K971663 — WELLCOLEX E.COLI O157:H7Murex Biotech , Ltd.·1997-12-30
• K972156 — QUIX RAPID E. COLI O157 STRIP TESTGuardian Scientific, Corp.·1997-10-16
• K942705 — E. COLI 0157 ELISA STOOL ASSAYLmd Laboratories·1995-09-27
• K944421 — E.COLI 0157 LATEX TESTPro-Lab Diagnostics·1994-12-15
• K884513 — PF TESTMedi-Tech, Inc.·1989-02-03