Product code GNA— Microbiology

FDA has cleared 12 devices under product code GNA between 1986 and 2007, filed by 10 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.

• 20071 clearance
• 20041 clearance
• 20001 clearance
• 19981 clearance
• 19961 clearance
• 19952 clearances
• 19941 clearance
• 19911 clearance
• 19891 clearance
• 19881 clearance
• 19861 clearance

• Oxoid U.S.A., Inc.2 clearances
• Meridian Diagnostics, Inc.2 clearances
• Remel Co.1 clearance
• Pro-Lab, Inc.1 clearance
• Pharmacia, Inc.1 clearance
• Oxoid , Ltd.1 clearance
• Murex Diagnostics, Inc.1 clearance
• Iverness Medical Professional Diagnostics1 clearance
• Emd Chemicals, Inc.1 clearance
• Denka Seiken'S1 clearance

• K071799 — MODIFICATION TO BIOSTAR OIA SHIGATOXIverness Medical Professional Diagnostics·2007-10-02
• K031367 — DUOPATH VEROTOXINS GLISA TESTEmd Chemicals, Inc.·2004-01-23
• K993401 — DRYSPOT E.COLI 0157 KITOxoid , Ltd.·2000-02-28
• K981734 — VTEC-RPLA SEIKENDenka Seiken'S·1998-09-22
• K962028 — WELLCOLEX E-COLI OI57 ZC60Murex Diagnostics, Inc.·1996-11-01
• K953362 — PREMIER EHECMeridian Diagnostics, Inc.·1995-11-14
• K950167 — PREMIER EHECMeridian Diagnostics, Inc.·1995-04-14
• K933457 — RIM E.COLI 0157:H7 LATEX TESTRemel Co.·1994-04-20
• K903714 — E. COLI 0157 LATEX TESTPro-Lab, Inc.·1991-01-24
• K884026 — ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KITOxoid U.S.A., Inc.·1989-02-03
• K874288 — PHADEBACT ETEC-LT TESTPharmacia, Inc.·1988-09-02
• K855234 — DIAGNOSTIC REAGENT VET-RPLAOxoid U.S.A., Inc.·1986-11-04