GNA · Class I · 21 CFR 866.3255

FDA Product Code GNA: Antisera, All Types, Escherichia Coli

Leading manufacturers include Meridian Diagnostics, Inc., Oxoid U.S.A., Inc. and Remel Co..

12
Total
12
Cleared
183d
Avg days
1986
Since

FDA 510(k) Cleared Antisera, All Types, Escherichia Coli Devices (Product Code GNA)

12 devices
1–12 of 12
Cleared Jan 23, 2004
DUOPATH VEROTOXINS GLISA TEST
K031367
Emd Chemicals, Inc.
Microbiology · 268d
Cleared Feb 28, 2000
DRYSPOT E.COLI 0157 KIT
K993401
Oxoid , Ltd.
Microbiology · 143d
Cleared Nov 14, 1995
PREMIER EHEC
K953362
Meridian Diagnostics, Inc.
Microbiology · 120d
Cleared Apr 14, 1995
PREMIER EHEC
K950167
Meridian Diagnostics, Inc.
Microbiology · 87d
Cleared Apr 20, 1994
RIM E.COLI 0157:H7 LATEX TEST
K933457
Remel Co.
Microbiology · 280d
Cleared Feb 03, 1989
ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT
K884026
Oxoid U.S.A., Inc.
Microbiology · 133d
Cleared Sep 02, 1988
PHADEBACT ETEC-LT TEST
K874288
Pharmacia, Inc.
Microbiology · 318d
Cleared Nov 04, 1986
DIAGNOSTIC REAGENT VET-RPLA
K855234
Oxoid U.S.A., Inc.
Microbiology · 308d

About Product Code GNA - Regulatory Context