JSS · Class I · 21 CFR 866.2660

FDA Product Code JSS: Kit, Identification, Enterobacteriaceae

Leading manufacturers include Advandx, Inc., Vitek Systems, Inc. and Bd Becton Dickinson Vacutainer Systems Preanalytic.

49
Total
49
Cleared
91d
Avg days
1976
Since
49 devices
25–48 of 49
Cleared Oct 02, 1981
MINITECK ENTERIC BROTH & ENTEROBACTER
K812286
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 50d
Cleared Aug 13, 1981
SENSITITIRE AP60
K811765
Gibco Laboratories Life Technologies, Inc.
Microbiology · 52d
Cleared Jun 26, 1981
SCEPTOR ID GRAM NEGATIVE MIC/ID PANELS
K811434
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 35d
Cleared Jan 11, 1980
ENTERIC-TEK
K792058
Flow Laboratories, Inc.
Microbiology · 88d
Cleared Nov 16, 1979
3M MICROBIAL PROFILE SYSTEM GRAM
K791789
3M Company
Microbiology · 63d
Cleared Nov 13, 1979
AMS ENTEROBACTERIACEASE CARE
K791932
Vitek Systems, Inc.
Microbiology · 47d
Cleared Jan 26, 1979
CORD, ENTEROBACTERIACEAE BIOCHEMICAL
K782056
Vitek Systems, Inc.
Microbiology · 46d
Cleared Sep 27, 1978
MS-2 BACTERIAL ID. SYSTEM
K781427
Abbott Laboratories
Microbiology · 36d
Cleared Aug 31, 1978
ENTEROTUBE II
K781236
Hoffmann-La Roche, Inc.
Microbiology · 42d
Cleared Oct 29, 1976
MICRO-ID
K760790
General Diagnostics
Microbiology · 22d