Kit, Identification, Enterobacteriaceae

FDA product code JSS · 48 cleared devices

Class 1 Microbiology

Regulation: 21 CFR 866.2660
Review panel: MI
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-10-29 – 2013-07-21

JSS 2013-07-21

GRAM-NEGATIVE QUICKFISH BC

Applicant Advandx, Inc.

K number K123418

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JSS 2010-12-16

GNR TRAFFIC LIGHT PNA FISH

Applicant Advandx, Inc.

K number K101558

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JSS 2009-12-16

E.COLI/P. AERUGINOSA PNA FISH

Applicant Advandx, Inc.

K number K092236

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JSS 2009-09-01

EK/P. AERUGINOSA PNA FISH

Applicant Advandx, Inc.

K number K092393

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JSS 2009-06-25

E. COLI PNA FISH

Applicant Advandx, Inc.

K number K082068

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JSS 2009-03-26

EK/P. AERUGINOSA PNA FISH

Applicant Advandx, Inc.

K number K081433

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JSS 2008-12-19

E.COLI/P. AERUGINOSA PNA FISH

Applicant Advandx, Inc.

K number K081309

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JSS 1993-09-23

ALAMAR BACTERIAL IDENTIFICATION TEST PANEL

Applicant Alamar Biosciences Laboratory, Inc.

K number K926002

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JSS 1993-03-11

CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM

Applicant Becton Dickinson Microbiology Systems

K number K926018

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JSS 1993-03-11

CRYSTAL RAPID STOOL/ENTERIC ID SYSTEM

Applicant Becton Dickinson Microbiology Systems

K number K926017

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JSS 1993-03-11

API 20E/UNISCEPT 20E

Applicant Analytical Products, Inc.

K number K924814

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JSS 1992-09-11

ROCHE ENTEROTUBE II

Applicant Roche Diagnostic Systems, Inc.

K number K922588

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JSS 1992-02-28

RAMBACH AGAR

Applicant Rantran, Inc.

K number K912924

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JSS 1989-08-31

SENSITITRE INDOLE REAGENT

Applicant Radiometer America, Inc.

K number K894776

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JSS 1989-06-02

RAPIDEC COLI

Applicant Dms Products, Inc.

K number K890626

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JSS 1988-09-16

VITEK GRAM-NEGATIVE IDENTIFICATION CARD

Applicant Vitek Systems, Inc.

K number K883558

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JSS 1986-09-30

GI MOTILITY TEST MEDIUM W/TTC

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K863603

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JSS 1986-05-20

QUADRA-TITER (TM) I.D. (MODIFICATION)

Applicant Microtech Medical Systems, Inc.

K number K861774

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JSS 1986-03-06

API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT)

Applicant Dms Products, Inc.

K number K854733

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JSS 1986-03-04

COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT

Applicant Roche Diagnostic Systems, Inc.

K number K853009

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JSS 1986-03-03

QUADRA-TITER I.D.

Applicant Microtech Medical Systems, Inc.

K number K860208

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JSS 1985-07-23

IDS RAPID SS/U SYSTEM

Applicant Innovative Diagnostic Systems, Inc.

K number K852871

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JSS 1985-06-04

IDS RAPID E PLUS SYSTEM

Applicant Innovative Diagnostic Systems, Inc.

K number K852110

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JSS 1985-06-04

LYFO-KWIK OMI KIT

Applicant Micro-Bio-Logics

K number K851978

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JSS 1984-10-01

RIM-UREA

Applicant Austin Biological Laboratories

K number K843571

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JSS 1984-01-13

TITERTEK ENTEROBAC*

Applicant Flow Laboratories, Inc.

K number K834090

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JSS 1983-12-12

FLUOR-B MEL A DIRECT FLUORESCENT ANTI

Applicant Petra Biomedical Products, Inc.

K number K833613

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JSS 1983-12-12

FLUOR-B. FRAG. DIRECT FLUORESCENT ANTI

Applicant Petra Biomedical Products, Inc.

K number K833612

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JSS 1983-06-22

SPECTRUM-10

Applicant Austin Biological Laboratories

K number K831672

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JSS 1983-04-08

QUANTUM II BACTERIAL IDENT. SYSTEM

Applicant Abbott Laboratories

K number K830698

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JSS 1983-03-08

UREA-PDA DISK

Applicant Remel Co.

K number K830396

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JSS 1982-02-04

RAPID E

Applicant Dms Laboratories

K number K813609

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JSS 1981-12-31

SYSTEK #1 EIKEN

Applicant Syn-Kit, Inc.

K number K813164

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JSS 1981-10-02

MINITECK ENTERIC BROTH & ENTEROBACTER

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K812286

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JSS 1981-08-13

SENSITITIRE AP60

Applicant Gibco Laboratories Life Technologies, Inc.

K number K811765

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JSS 1981-06-26

SCEPTOR ID GRAM NEGATIVE MIC/ID PANELS

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K811434

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JSS 1980-01-11

ENTERIC-TEK

Applicant Flow Laboratories, Inc.

K number K792058

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JSS 1979-11-16

3M MICROBIAL PROFILE SYSTEM GRAM

Applicant 3M Company

K number K791789

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JSS 1979-11-13

STREP-SPEC

Applicant Micro-Media Systems, Inc.

K number K791991

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JSS 1979-11-13

AMS ENTEROBACTERIACEASE CARE

Applicant Vitek Systems, Inc.

K number K791932

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JSS 1979-01-26

CORD, ENTEROBACTERIACEAE BIOCHEMICAL

Applicant Vitek Systems, Inc.

K number K782056

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JSS 1978-12-07

INOCULATOR, AIM-4 MICROPROCESSOR

Applicant Axford Manufacturing , Ltd.

K number K781816

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JSS 1978-10-03

MICRODILUTION GRAM-NEGATIVE ID. PANEL

Applicant Cnr Labs

K number K781368

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JSS 1978-10-03

MICRODILUTION STREP ID. PANEL

Applicant Cnr Labs

K number K781367

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JSS 1978-09-27

MS-2 BACTERIAL ID. SYSTEM

Applicant Abbott Laboratories

K number K781427

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JSS 1978-08-31

ENTEROTUBE II

Applicant Hoffmann-La Roche, Inc.

K number K781236

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JSS 1977-10-04

ENTERIC 20

Applicant Inolex Corp./Div of Biomedical

K number K771703

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JSS 1976-10-29

MICRO-ID

Applicant General Diagnostics

K number K760790

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