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Kit, Screening, Urine

FDA product code JXA · 44 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: 1977-12-09 – 2001-11-30

JXA 2001-11-30

OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)

Applicant Osmetech

K number K011043

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JXA 1998-10-07

URISCREEN

Applicant Diatech Diagnostics,Inc.

K number K981084

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JXA 1998-02-23

URINE SCREENING DEVICE

Applicant Combact Diagnostic Systems , Ltd.

K number K972676

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JXA 1995-06-20

TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT

Applicant Tri-Tech, Inc.

K number K952246

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JXA 1995-04-14

MULTIPLE (IZON DBS & URINE COLLECTION KIT)

Applicant Izon Business Products, Inc.

K number K950257

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JXA 1995-03-21

MULTIPLE (IZON URINE COLLECTION KIT)

Applicant Izon Business Products, Inc.

K number K950246

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JXA 1995-03-21

MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)

Applicant Izon Business Products, Inc.

K number K950221

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JXA 1994-09-09

CULTURIA MACCONKEY-MUG

Applicant Clinical Convenience Products, Inc.

K number K934759

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JXA 1993-02-03

BAC-T-SCREEN

Applicant Biomerieux Vitek, Inc.

K number K924218

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JXA 1992-09-28

DIASLIDE URINE CULTURING DEVICE

Applicant Savyon Diagnostics , Ltd.

K number K921045

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JXA 1991-10-04

URI-THREE(TM), MODIFICATION

Applicant Culture Kits, Inc.

K number K911846

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JXA 1990-12-13

QUALTURE

Applicant Future Medical Technologies Intl., Inc.

K number K903470

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JXA 1989-09-26

RAPIDEC UR

Applicant Dms Products, Inc.

K number K894805

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JXA 1989-09-15

GEN-PROBE PACE SYSTEM URINE SCREEN

Applicant Gen-Probe, Inc.

K number K892216

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JXA 1988-09-30

URISCREEN

Applicant Diatech Diagnostica , Ltd.

K number K882211

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JXA 1988-09-07

RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST

Applicant Los Alamos Diagnostics

K number K883385

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JXA 1988-04-28

MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM

Applicant Los Alamos Diagnostics

K number K881439

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JXA 1987-08-24

ROUND 1

Applicant Bioclinical Systems, Inc.

K number K873086

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JXA 1987-06-17

LYFO KWIK(TM) RUS KIT

Applicant Micro-Bio-Logics

K number K870731

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JXA 1987-02-24

N-D URINE TUBE SYSTEM (N-D TUBE/CAP/PIPETTE)

Applicant Cls Co.

K number K864177

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JXA 1987-02-13

UTISCREEN(R) BACTERIAL ATP TEST

Applicant Los Alamos Diagnostics

K number K864202

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JXA 1986-06-30

RAPID BACTERIURIA SCREEN (RBS)

Applicant New Horizons Diagnostics Co.

K number K862195

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JXA 1986-06-10

SLIDE CULTURE U 'EIKEN'

Applicant Syn-Kit, Inc.

K number K861631

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JXA 1986-04-04

URICHECK

Applicant Difco Laboratories, Inc.

K number K860905

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JXA 1986-04-04

FILTRA-CHECK-UTI

Applicant Applied Polytechnology, Inc.

K number K860483

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JXA 1985-06-04

BAC-T-SCREEN

Applicant Marion Laboratories, Inc.

K number K851399

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JXA 1984-11-29

BACTERIURIA DETECT. DEVICE APTEK II

Applicant Applied Polytechnology, Inc.

K number K843834

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JXA 1984-11-29

BACTERIURIA DETECT DEVICE, MULTI SAMPLER

Applicant Applied Polytechnology, Inc.

K number K843833

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JXA 1984-03-12

ORTHO BACTERIURIA DETECTION SYS

Applicant Ortho Diagnostic Systems, Inc.

K number K833834

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JXA 1983-11-14

BACTERUERIA SCREENING PROCEDURE

Applicant Turner Designs, Inc.

K number K832975

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JXA 1983-03-07

DIPCHEX DIP-SLIDE CULTURE SYS

Applicant Granite Diagnostics, Inc.

K number K830252

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JXA 1983-03-01

BAC-T-SCREEN BACTERIURIA DETECTION DEV

Applicant Marion Laboratories, Inc.

K number K823850

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JXA 1983-01-07

RAPID BACTERIURIA SCREENING TEST

Applicant Analytical Luminescence Laboratory, Inc.

K number K820126

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JXA 1981-07-31

LUMAC'S BACTERIURIA SCREENING KIT

Applicant Lumac

K number K810746

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JXA 1980-04-24

URI-DIP (R)

Applicant Pharma-Medica of Scandinavia, Ltd.

K number K800626

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JXA 1980-02-13

CULTURIA MACCONKEY/CLED #DM87

Applicant Clinical Convenience Products, Inc.

K number K800215

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JXA 1980-01-11

CULTURIA MACCONKEY/COLUMBIA CNA

Applicant Clinical Convenience Products, Inc.

K number K792579

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JXA 1979-12-19

CULTURIA EMB/COLUMBIA CNA W/5% SHEEP

Applicant Clinical Convenience Products, Inc.

K number K792284

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JXA 1978-09-20

MS-2 AUTOMATED URINE SCREENING SYSTEM

Applicant Abbott Laboratories

K number K781370

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JXA 1978-09-14

VAC-U-PAC KIDNEY CASSETTE

Applicant E-Z-Em, Inc.

K number K781536

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JXA 1978-06-06

TILL-U-TEST, DIP SLIDE

Applicant Biotron , Ltd.

K number K780803

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JXA 1978-03-17

URINE SCREENING KITS

Applicant Diagnostic Culture System

K number K780021

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JXA 1978-01-31

TILL-U=TEST

Applicant Clinifax Industries, Ltd.

K number K780109

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JXA 1977-12-09

MICROCULT-ID

Applicant Miles Laboratories, Inc.

K number K771672

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