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Device, Specimen Collection

FDA product code LIO · 63 cleared devices

Class 1 Microbiology

Regulation: 21 CFR 866.2900
Review panel: MI
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1982-05-14 – 2024-03-27

LIO 2024-03-27

ARX Liquid Amies Collection & Transport System

Applicant Arx Sciences, Inc.

K number K222613

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LIO 2013-10-21

PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM

Applicant Puritan Medical Products, LLC

K number K131630

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LIO 2012-06-08

TRANSPORT CULTURE MEDIUM DEVICE

Applicant Puritan Medical Products, LLC

K number K120846

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LIO 2011-01-25

MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE

Applicant Medical Wire & Equipment Company (Bath), Ltd.

K number K103805

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LIO 2008-12-30

VIROCULT, MODEL MW950

Applicant Medical Wire & Equipment Company (Bath), Ltd.

K number K082472

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LIO 2007-07-30

COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE

Applicant Diesse Diagnostica Senese S.P.A.

K number K070062

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LIO 2001-11-26

BACTI-SWAB DRY

Applicant Remel Co.

K number K013711

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LIO 2001-05-31

NAT - NUCLEIC ACID TRANSPORT

Applicant Medical Packaging Corp.

K number K003761

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LIO 1999-03-15

ENTERO-TEST HP, MODEL #102-01

Applicant Hdc Corp.

K number K983119

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LIO 1998-07-14

PAR-ONE

Applicant Remel, Inc.

K number K981391

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LIO 1996-11-27

PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF - PCP-MF

Applicant Para Scientific Co.

K number K964144

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LIO 1996-11-08

STP SYSTEM PVA WITH ZINC

Applicant Sage Products, Inc.

K number K963986

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LIO 1996-11-07

STP SYSTEM - SAF

Applicant Sage Products, Inc.

K number K964026

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LIO 1996-11-01

STP SYSTEM-PVA WITH MERCURY

Applicant Sage Products, Inc.

K number K964027

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LIO 1996-04-03

STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM

Applicant Starplex Scientific, Inc.

K number K960997

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LIO 1995-11-16

MID-STREAM COLLECTION SET-STERILE

Applicant Trinity Laboratories, Inc.

K number K953929

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LIO 1995-04-05

PINWORM EGG COLLECTOR

Applicant Evergreen Industries, Inc.

K number K950096

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LIO 1993-06-15

PARA-PAK PLUS

Applicant Meridian Diagnostics, Inc.

K number K931770

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LIO 1993-06-15

ZINC PVA

Applicant Remel Co.

K number K931383

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LIO 1993-03-18

APEX SPECIMEN BAG

Applicant Apex Medical Technologies, Inc.

K number K930313

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LIO 1993-01-15

CYTOQUANT COMBINED TRANSPORT MEDIA

Applicant Proteins Intl., Inc.

K number K924053

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LIO 1992-12-24

TRANSYSTEM LIQUID STUART MEDIUM

Applicant Pro-Lab Diagnostics

K number K924331

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LIO 1992-12-24

TRANSYSTEM AMIES WITH CHARCOAL

Applicant Pro-Lab Diagnostics

K number K924330

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LIO 1992-12-24

TRANSYSTEM AMIES W/O CHARCOAL

Applicant Pro-Lab Diagnostics

K number K924329

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LIO 1992-12-24

TRANSYSTEM LIQUID AMIES MEDIUM

Applicant Pro-Lab Diagnostics

K number K924328

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LIO 1992-07-30

AFFIRM VP SAMPLE COLLECTION SET

Applicant Microprobe Corp.

K number K920536

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LIO 1992-06-19

URINE CULTUR STABILIZATION TRANSPORT TUBE

Applicant Bio Medicus, Inc.

K number K920761

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LIO 1992-04-08

CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT

Applicant Medical Packaging Corp.

K number K915454

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LIO 1991-08-22

BACTI-SWAB(TM) NPG

Applicant Remel Co.

K number K912832

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LIO 1991-07-30

BACTI-SWAB(TM) II

Applicant Remel Co.

K number K912831

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LIO 1991-01-18

GASTRO-INTESTINAL ACCU-CULSHURE TM

Applicant Medical Laboratory Automation Systems, Inc.

K number K903638

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LIO 1990-12-17

SAF FIXATIVE

Applicant Gibson Laboratories, Inc.

K number K905120

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LIO 1990-10-16

VIRAL ACCU-CULSHURE TM

Applicant Medical Laboratory Automation Systems, Inc.

K number K903406

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LIO 1990-10-16

CHLAMYDIA ACCU-CULSHURE TM

Applicant Medical Laboratory Automation Systems, Inc.

K number K903405

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LIO 1990-08-22

FLORA-STAT URINE TRANSPORT SYSTEM

Applicant Wadley Biosciences Corp.

K number K902467

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LIO 1990-03-01

SPECIMEN CONTAINER

Applicant Westmark, Sterile Packing Systems, Inc. (Sps)

K number K896794

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LIO 1990-02-02

ROMCHECK SPECIMEN COLLECTION KIT

Applicant Adeza Biomedical

K number K900225

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LIO 1989-08-03

PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1)

Applicant Diagnostic Products Corp.

K number K893905

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LIO 1989-04-21

FTK FECAL TRANSPORT KIT

Applicant Evergreen Scientific, Inc.

K number K890134

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LIO 1988-11-03

NOVAPATH SPECIMEN COLLECTION KIT

Applicant Bio-Rad

K number K884342

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LIO 1988-07-18

DIVERSI-KIT

Applicant Intl. Cancer Screening Laboratories, Inc.

K number K882485

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LIO 1988-05-13

SNAP(R) ROTAVIRUS DIAGNOSTIC KIT

Applicant Molecular Biosystems, Inc.

K number K873565

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LIO 1988-03-23

PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KIT

Applicant Kallestad Diag, A Div. of Erbamont, Inc.

K number K881125

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LIO 1987-11-24

CHLAMYDIA STAT DIRECT SMEAR COLLECTION KIT

Applicant Tm & M C/O Burditt,Bowles,Radzius & Ruberry, Ltd.

K number K874456

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LIO 1987-07-23

FLUORTRAN - C(TM)

Applicant Para Scientific Co.

K number K872751

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LIO 1987-05-29

NOVAPATH C. TRACHOMATIS DIRECT SPEC COLLECTION KIT

Applicant Bio-Rad

K number K871860

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LIO 1987-04-08

MODIFIED PATHFINDER SPECIMEN COLLECTION KIT

Applicant Kallestad Diag, A Div. of Erbamont, Inc.

K number K870963

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LIO 1987-02-04

KULTSURE

Applicant Ncs Diagnostics, Inc.

K number K870231

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LIO 1987-01-05

CULT-UR

Applicant R.P. Laboratories, Inc.

K number K864727

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LIO 1986-08-04

IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT

Applicant Boots-Celltech Diagnostics, Inc.

K number K862607

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LIO 1986-03-06

KULTSURE (CATALOGUE NO. M200)

Applicant Ncs Diagnostics, Inc.

K number K860655

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LIO 1986-02-24

LUNG CARE (SPECIMEN TRANSPORT & STORAGE CONTAINER)

Applicant Xsirius Scientific, Inc.

K number K854719

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LIO 1985-06-21

VIRTRAN VIRAL TRANPORTER

Applicant Diagnon Corp.

K number K851378

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LIO 1985-05-20

MICROSTATIC URINE TRANSPORT TUBE FOR C & S

Applicant Analytical Luminescence Laboratory, Inc.

K number K851387

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LIO 1985-02-06

MICRO ORGANISM GROWTH SYS-M1000

Applicant Hml Inc/Biotechnology Transfer

K number K843000

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LIO 1984-10-23

MODIFICATION MICROTRAK DIRECT SPECIMEN TEST

Applicant Syva Co.

K number K843935

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LIO 1984-06-07

V.D.T.-GONORRHEA TEST KIT

Applicant M.G. Laboratories, Inc.

K number K840799

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LIO 1984-03-19

SANI CATCH BA

Applicant Concord Laboratories, Inc.

K number K833814

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LIO 1984-02-04

PRESERV SAF FIXATIVE 15ML

Applicant Preventive Diagnostics Corp.

K number K834566

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LIO 1984-01-30

PRESERV MF FIXATIVE 15ML

Applicant Preventive Diagnostics Corp.

K number K840086

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LIO 1983-09-29

COLLECTION KIT CHLAMYDIA TRACHOMATIS

Applicant Syva Co.

K number K832079

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LIO 1983-09-26

DUPONT ISOLATOR 1.5 MICROBIAL TUBE

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K832246

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LIO 1982-05-14

VD ALERT

Applicant Intl. Research Distributors, Inc.

K number K820520

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