Culture Media, Non-Propagating Transport

FDA product code JSM · 107 cleared devices

Class 1 Microbiology

Regulation: 21 CFR 866.2390
Review panel: MI
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1979-08-22 – 2025-11-26

JSM 2025-11-26

Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device

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

K number K242976

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JSM 2025-09-22

Babio® Virus Transport Kit (Non-inactivating)

Applicant Jinan Babio Biotechnology Co., Ltd.

K number K250205

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JSM 2025-04-04

AllTest Viral Transport Medium

Applicant Hangzhou AllTest Biotech Co., Ltd.

K number K242576

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JSM 2024-10-11

UriSponge™

Applicant Copan Italia Spa

K number K232565

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JSM 2024-08-29

Ensol EnTM Specimen Collection and Transport System

Applicant Ensol Biosciences, Inc.

K number K220908

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JSM 2024-08-19

OmniTrans Transport System

Applicant Shenzhen Dakewe Bio-Engineering Co., Ltd.

K number K240235

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JSM 2024-08-02

Viral Transport Medium

Applicant Hardy Diagnostics

K number K233534

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JSM 2024-07-15

Avantik VTM

Applicant Hanchang Medic Co., Ltd. (Han Chang Medic)

K number K233449

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JSM 2024-05-03

Viral Transport Media (VTM)

Applicant Alb Luz

K number K232454

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JSM 2024-04-25

Copan Universal Transport Medium (UTM-RT) System

Applicant Copan Italia Spa

K number K232357

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JSM 2024-04-11

Azer Scientific Universal Transport Medium

Applicant Azer Scientific, Inc.

K number K202531

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JSM 2024-03-19

ARX Viral Transport Media Collection and Transport System

Applicant Arx Sciences, Inc.

K number K231843

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JSM 2023-12-21

KaiBiLi Extended ViralTrans

Applicant Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.

K number K231027

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JSM 2023-05-03

MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System

Applicant Medschenker, Inc.

K number K212743

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JSM 2023-04-05

BioSci™ Disposable Virus Sampling Tubes

Applicant Shenzhen Dakewe Bio-Engineering Co., Ltd.

K number K230035

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JSM 2022-12-16

Copan FecalSwab Collection, Transport and Preservation System

Applicant Copan Italia Spa

K number K220052

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JSM 2022-11-17

Disposable Urine Collection Tube

Applicant Zhejiang Gongdong Medical Technology Co., Ltd.

K number K220739

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JSM 2022-08-18

iClean Viral Transport System (VTM-RT kit)

Applicant Huachenyang (Shenzhen) Technology Co. , Ltd.

K number K212856

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JSM 2022-05-20

Disposable Sampler Viral Transport Media

Applicant Wuxi Nest Biotechnology Co., Ltd.

K number K211256

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JSM 2022-05-04

BioTeke Sterile Disposable Virus Sampling Kit

Applicant Bioteke Corporation (Wuxi) Co., Ltd.

K number K211707

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JSM 2021-03-03

Cultura Collection and Transport System

Applicant Merit Medical Systems, Inc.

K number K201674

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JSM 2018-03-23

UriSwab-Urine Collection, Transport and Preservation System

Applicant Copan Italia Spa

K number K180052

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JSM 2017-03-06

Greiner Vacuette Urine Count and Culture, Mannitol tube

Applicant Greiner Bio-One Na, Inc.

K number K163436

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JSM 2016-11-04

Puritan Fecal Opti-Swab Collection and Transport System

Applicant Puritan Medical Products, LLC

K number K162284

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JSM 2016-07-29

Puritan Opti-Tranz Cary-Blair Collection and Transport System

Applicant Puritan Medical Products, LLC

K number K160082

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JSM 2012-03-01

TRANSPORT CULTURE MEDIUM DEVICE

Applicant Puritan Medical Products, LLC

K number K113249

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JSM 2004-12-07

COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM

Applicant Copan Diagnostics, Inc.

K number K042970

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JSM 2003-08-13

MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM

Applicant Starplex Scientific, Inc.

K number K032246

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JSM 2003-04-14

URINE MONOVETTE BORIC ACID

Applicant Sarstedt, Inc.

K number K024237

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JSM 2003-03-26

BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS

Applicant Bd

K number K024240

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JSM 2001-07-31

COPAN VIRAL TRANSYSTEM

Applicant Copan Diagnostics, Inc.

K number K001780

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JSM 1999-12-21

CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL R96 K, VIRAL TRANSPORT KIT, MODEL R99 K

Applicant Hardy Diagnostics

K number K993812

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JSM 1997-10-08

SNAP SWAB CULTURE COLLECTION AND TRANSPORT SYSTEM

Applicant Medical Packaging Corp.

K number K972726

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JSM 1997-03-24

CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM WITH CLINICAL TRANSPORT MEDIA (CARY-BLAIR OPTION)

Applicant Medical Packaging Corp.

K number K970597

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JSM 1997-01-22

A.C.T. II

Applicant Remel Co.

K number K965152

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JSM 1997-01-22

A.C.T. III

Applicant Remel Co.

K number K965151

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JSM 1997-01-22

A.C.T. IV

Applicant Remel Co.

K number K965150

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JSM 1997-01-22

A.C.T. I

Applicant Remel Co.

K number K965149

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JSM 1996-12-24

CULTURE COLLECTION AND TRANSPORT SYSTEM, MODIFIED AMIES MEDIA

Applicant Medical Packaging Corp.

K number K964637

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JSM 1996-09-18

MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM

Applicant Starplex Scientific, Inc.

K number K962843

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JSM 1996-09-18

10B ARGININE BROTH

Applicant Remel, L.P.

K number K961046

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JSM 1996-07-22

CVM TRANSPORT

Applicant Hardy Diagnostics

K number K955451

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JSM 1995-03-10

COPAN VENTURI TRANSYSTEM LIQUID AMIES MEDIUM

Applicant Copan Diagnostics, Inc.

K number K946288

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JSM 1995-03-10

COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL

Applicant Copan Diagnostics, Inc.

K number K946287

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JSM 1995-03-10

COPAN VENTURI TRANSYSTEM CARY-BLAIR MEDIUM

Applicant Copan Diagnostics, Inc.

K number K946286

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JSM 1995-03-10

COPAN VENTURI TRANSYSTEM STUARTS MEDIUM

Applicant Copan Diagnostics, Inc.

K number K946285

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JSM 1995-03-10

COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL

Applicant Copan Diagnostics, Inc.

K number K946284

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JSM 1995-03-10

COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUM

Applicant Copan Diagnostics, Inc.

K number K946283

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JSM 1994-11-30

KULTSURE STARSWAB(M240), MODIFICATION

Applicant Ncs Diagnostics, Inc.

K number K943499

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JSM 1994-11-30

KULTSURE STARSWAB (M210), MODIFICATION

Applicant Ncs Diagnostics, Inc.

K number K943498

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JSM 1994-10-21

MODIFIED MICRO TEST MULTI MICROBE MEDIUM (M5)

Applicant Microtest

K number K941579

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JSM 1994-08-16

CULTURE-PAK COLLECTION/TRANSPORT SYSTEM, MODIFIED

Applicant Medical Packaging Corp.

K number K936078

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JSM 1994-08-16

CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM

Applicant Medical Packaging Corp.

K number K932337

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JSM 1994-08-15

FLEXTRANS

Applicant Baxter Diagnostics, Inc.

K number K935987

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JSM 1994-04-21

SPECIMEN TRANSPORT MEDIUM

Applicant Biowhittaker Molecular Applications, Inc.

K number K935618

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JSM 1994-03-30

DIADOT(TM) VIRUS/CHLAMYDIA TRANSPORT

Applicant Viratest Intl., Inc.

K number K931922

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JSM 1992-05-06

M4-RT TRANSPORT MEDIUM, (M4 MODIFICATION)

Applicant Microtest

K number K921472

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JSM 1991-12-18

VIRAPURE, CHLAMYPURE AND MYCOPURE

Applicant Microtest

K number K914894

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JSM 1991-10-09

AEROBIC FOAM SWAB CULTURETTE(R)

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K913789

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JSM 1991-05-10

BACTI-SWAB

Applicant Remel Co.

K number K910180

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JSM 1991-04-09

MICROTEST MULTI MICROBE MEDIUM

Applicant Microtest

K number K910526

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JSM 1989-03-21

CARY-BLAIR TRANSPORT SYSTEM

Applicant Precision Biologicals, Inc.

K number K885245

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JSM 1989-03-21

SAF FECAL COLLECTION KIT

Applicant Precision Biologicals, Inc.

K number K885244

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JSM 1988-04-25

CULTURE COLLECTION DEVICE

Applicant Medical Packaging Corp.

K number K881105

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JSM 1988-04-18

STUARTS TRANSPORT MEDIUM

Applicant Acumedia Manufacturers, Inc.

K number K881569

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JSM 1988-04-18

AMIES TRANSPORT MEDIUM

Applicant Acumedia Manufacturers, Inc.

K number K881539

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JSM 1988-04-18

CARY AND BLAIR TRANSPORT MEDIUM

Applicant Acumedia Manufacturers, Inc.

K number K881529

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JSM 1987-07-09

PRECISION CULTURE C.A.T.S. COLLECT/TRANS HSV I/II

Applicant Precision Dynamics Corp.

K number K872507

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JSM 1987-06-23

TRANSTUBE MW176 OT MD176

Applicant Medical Wire & Equipment Co.

K number K872213

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JSM 1987-04-21

KULTSURE

Applicant Ncs Diagnostics, Inc.

K number K871404

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JSM 1987-04-20

IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT

Applicant Boots-Celltech Diagnostics, Inc.

K number K864998

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JSM 1987-04-14

CHLAMYDIA & VIRAL TRANSPORT MEDIUM

Applicant R. Kent Richards, Inc.

K number K871065

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JSM 1987-03-31

CARY BLAIR TRANSPORT MEDIUM

Applicant Mds Laboratories, Inc.

K number K864237

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JSM 1986-10-10

PATHFINDER(TM) SPECIMEN COLLECTION KIT

Applicant Kallestad Laboratories, Inc.

K number K863682

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JSM 1986-09-30

BUFFERED GLYCEROL SALINE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K863602

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JSM 1986-09-19

CARY-BLAIR TRANSPORT MEDIUM

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K863527

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JSM 1986-08-27

AGAR REDUCTION IN FORMULA FOR PDC 110 & 310 MEDIA

Applicant Precision Dynamics Corp.

K number K863164

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JSM 1986-04-07

CELLEMATICS VIRAL/CHLAMYDAL TRANSPORT PACK(MODIFI)

Applicant Difco Laboratories, Inc.

K number K861080

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JSM 1986-04-04

KULTSURE (CULTURE TRANSPORT)

Applicant Ncs Diagnostics, Inc.

K number K860178

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JSM 1986-03-04

KULTSURE (CATALOGUE NO. M250)

Applicant Ncs Diagnostics, Inc.

K number K860658

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JSM 1986-03-04

KULTSURE (CATALOGUE NO. M240)

Applicant Ncs Diagnostics, Inc.

K number K860657

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JSM 1986-03-04

KULTSURE (CATALOGUE NO. M210)

Applicant Ncs Diagnostics, Inc.

K number K860656

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JSM 1986-01-03

BBL PORT-A-CUL AEROBIC TRANSPORT SYS, MODIFIED STU

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K854986

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JSM 1985-12-23

TRANSPORT CULTURE MEDIA

Applicant Hillcrest Biologicals

K number K854715

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JSM 1985-10-23

SYVA MYCOTRANS MYCOPLASMA TRANSPORT SYSTEM

Applicant Syva Co.

K number K854061

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JSM 1985-08-28

ORTHO VIRAL TRANSPORT

Applicant Ortho Diagnostic Systems, Inc.

K number K853500

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JSM 1985-03-22

AMIES TRANSPORT MEDIA

Applicant Rapid City Regional Hospital, Inc.

K number K850717

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JSM 1985-03-04

CHLAMYDIAL TRANSPORT MEDIA

Applicant Hillcrest Biologicals

K number K850124

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JSM 1985-01-30

PDC 104 & PDC 304 STYLE CULTURE COLLECTION & TRANS

Applicant Precision Dynamics Corp.

K number K844634

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JSM 1985-01-04

VIRAL TRANSPORT MEDIA

Applicant Hillcrest Biologicals

K number K844747

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JSM 1985-01-04

BBL PORT-A-CUL 21627 SINGLE SWAB CULTURE COLLECT

Applicant Precision Dynamics Corp.

K number K844370

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JSM 1985-01-04

BBL PORT-A-CUL 21628 DOUBLE SWAB SULTURE COLLECTIO

Applicant Precision Dynamics Corp.

K number K844369

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JSM 1984-04-04

NON PROPAGATING TRANSPORT

Applicant Smith River Biologicals

K number K841205

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JSM 1984-02-13

CHLAMYDIAL TRANSPORT MEDIUM

Applicant Bartels Immunodiagnostic Supplies, Inc.

K number K834125

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JSM 1984-01-13

WATER W/TWEEN 80

Applicant Hardy Media

K number K834316

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JSM 1984-01-13

STERILE SALINE 0.85%

Applicant Hardy Media

K number K834315

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JSM 1983-04-28

I/A KIT

Applicant Staar Surgical Co.

K number K831159

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JSM 1983-04-28

P & T MEDIUM

Applicant American Micro Scan

K number K831059

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JSM 1982-11-16

CHLAMYDIA TRANSETTEE 1 & 3

Applicant Spectrum Co.

K number K823179

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JSM 1982-10-27

GONORRHEA TRANSETTE 3

Applicant Spectrum Diagnostic, Inc.

K number K822886

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