JTO · Class I · 21 CFR 866.2660

FDA Product Code JTO: Discs, Strips And Reagents, Microorganism Differentiation

Leading manufacturers include Remel Co., Difco Laboratories, Inc. and Dms Laboratories.

244
Total
244
Cleared
59d
Avg days
1976
Since
244 devices
145–168 of 244
Cleared Aug 26, 1983
ONPG DISCS
K832307
Oxoid U.S.A., Inc.
Microbiology · 43d
Cleared Aug 24, 1983
SPS DISCS
K832305
Oxoid U.S.A., Inc.
Microbiology · 41d
Cleared Aug 24, 1983
BILE AESCULIN DISCS
K832306
Oxoid U.S.A., Inc.
Microbiology · 41d
Cleared Jun 30, 1983
OXY-SWAB
K831673
Austin Biological Laboratories
Microbiology · 38d
Cleared Jun 30, 1983
RIM-CAMP TEST
K831674
Austin Biological Laboratories
Microbiology · 38d
Cleared Jun 22, 1983
RIM BETA LACTAMASE TEST
K831654
Austin Biological Laboratories
Microbiology · 30d
Cleared Jun 16, 1983
RAPID IDENTIFI-METHOD NEISSERIA KIT
K830968
Austin Biological Laboratories
Microbiology · 80d
Cleared May 09, 1983
TRP
K831187
Dms Laboratories
Microbiology · 27d
Cleared Apr 13, 1983
THYMINE/THYMIDINE DISCS DDG
K830939
Oxoid U.S.A., Inc.
Microbiology · 20d
Cleared Feb 28, 1983
LYSOSTAPHIN REAGENT SET
K830323
Remel Co.
Microbiology · 28d
Cleared Feb 15, 1983
MS-2 BACTERIAL IDENTI. SYS
K830099
Abbott Laboratories
Microbiology · 35d
Cleared Feb 07, 1983
SCEPTOR GRAM-POSITIVE PANEL, MIC/10 TEMP
K823718
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 59d
Cleared Nov 12, 1982
BACTEC NAP TB DIFFERENTIATION TEST
K822946
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 39d
Cleared Nov 01, 1982
CSM CHROMOGENIC B-LACTAMASE DISC
K822930
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 28d
Cleared Jul 22, 1982
NEIDENT*
K821907
Analytical Products, Inc.
Microbiology · 24d
Cleared May 03, 1982
AMS GRAM-POSITIVE IDENTIFICATION CARD
K820264
Vitek Systems, Inc.
Microbiology · 90d
Cleared May 03, 1982
RAPID SST
K821040
Mds Laboratories, Inc.
Microbiology · 20d
Cleared Feb 22, 1982
RAPID ZYME
K813612
Dms Laboratories
Microbiology · 55d
Cleared Feb 22, 1982
RAPID CH
K813613
Dms Laboratories
Microbiology · 55d
Cleared Feb 12, 1982
ZYME B
K820209
Dms Laboratories
Microbiology · 17d
Cleared Feb 12, 1982
IND
K820210
Dms Laboratories
Microbiology · 17d
Cleared Feb 12, 1982
NINHYDRIN
K820211
Dms Laboratories
Microbiology · 17d
Cleared Feb 12, 1982
OXI
K820212
Dms Laboratories
Microbiology · 17d
Cleared Feb 12, 1982
SALINE SOLUTION
K820213
Dms Laboratories
Microbiology · 17d