System, Test, Infectious Mononucleosis

FDA product code KTN · 59 cleared devices

Class 2 Immunology

Regulation: 21 CFR 866.5640
Review panel: MI
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-08-03 – 2018-06-22

KTN 2018-06-22

OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test

Applicant SEKISUI Diagnostics, LLC

K number K181436

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KTN 2005-02-28

ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)

Applicant ACON Laboratories, Inc.

K number K042272

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KTN 2003-02-24

BIORAPID MONONUCLEOSIS

Applicant Instrumentation Laboratory CO

K number K030215

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KTN 2001-09-27

COLOR-MONOGEN

Applicant Instrumentation Laboratory CO

K number K012901

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KTN 1999-01-28

DRYSPOT INFECTIOUS MONONUCLEOSIS KIT

Applicant Oxoid , Ltd.

K number K982634

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KTN 1998-12-10

CLEARVIEW IM

Applicant Unipath , Ltd.

K number K981946

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KTN 1997-12-01

MONOCOL/LEX-IM TEST

Applicant Immunostics Inc.,

K number K972457

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KTN 1997-08-26

OSOM MONO TEST 143

Applicant Wyntek Diagnostics, Inc.

K number K972231

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KTN 1997-02-25

GENZYME DIAGNOSTICS CONTRAST MONO

Applicant Genzyme Diagnostics

K number K963425

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KTN 1997-02-04

BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB

Applicant Princeton BioMeditech Corp.

K number K961024

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KTN 1996-09-24

QUALITROL MONO CONTROL SERUM SET

Applicant Consolidated Technologies, Inc.

K number K961550

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KTN 1993-12-27

IMMUNOCARD MONO

Applicant Meridian Diagnostics, Inc.

K number K930778

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KTN 1993-09-08

EYE SPOT IM TEST

Applicant J.S. Medical Assoc.

K number K932688

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KTN 1993-08-09

ACCUTEX IM LATEX TEST

Applicant J.S. Medical Assoc.

K number K932551

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KTN 1993-02-23

BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST

Applicant Princeton Biomedix

K number K925183

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KTN 1992-11-02

ACCUTEX IM RBC TEST

Applicant J.S. Medical Assoc.

K number K924037

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KTN 1992-10-16

PULSE IM RED CELL TEST

Applicant Pulse Scientific, Inc.

K number K923767

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KTN 1992-10-05

TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL

Applicant Simplicity Diagnostics, Inc.

K number K922726

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KTN 1992-07-14

INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST

Applicant Ampcor, Inc.

K number K922297

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KTN 1992-07-14

IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST

Applicant Ampcor, Inc.

K number K922296

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KTN 1992-03-13

HEALTHTEST INFECTIOUS MONONUCLEOSIS ASSAY

Applicant Akers Research Corp.

K number K920221

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KTN 1990-07-16

CARDS O.S. MONO

Applicant Pacific Biotech, Inc.

K number K902510

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KTN 1990-06-28

MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX

Applicant Trinity Laboratories, Inc.

K number K902541

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KTN 1990-02-26

MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET

Applicant Armkel, LLC

K number K900625

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KTN 1990-01-26

DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS CONTROLS

Applicant Quidel Corp.

K number K896926

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KTN 1989-10-31

DETECTADOT SYSTEM 2000 HETEROPHILE TEST

Applicant Gull Laboratories, Inc.

K number K895891

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KTN 1989-10-31

LEECO PREVIEW(R) EBV (EIA)

Applicant Leeco Diagnostics, Inc.

K number K895765

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KTN 1989-09-13

IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST

Applicant General Biometrics, Inc.

K number K894975

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KTN 1989-08-21

MONODEX

Applicant Cenogenics Corp.

K number K894793

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KTN 1989-06-16

DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST

Applicant Quidel Corp.

K number K893737

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KTN 1989-03-16

MONO-CUBE(TM)

Applicant Difco Laboratories, Inc.

K number K890991

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KTN 1989-01-23

V-TREND TARGET IM TEST

Applicant Texas Immunology, Inc.

K number K890041

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KTN 1988-12-20

MODIFICATION OF MONO-PLUS(TM)

Applicant Armkel, LLC

K number K883709

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KTN 1988-11-18

CARDS(TM) MONO

Applicant Pacific Biotech, Inc.

K number K884007

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KTN 1988-10-19

OXOID INFECTIOUS MONONUCLEOSIS KIT

Applicant Unipath , Ltd.

K number K883540

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KTN 1988-08-04

MONO-PLUS(TM)

Applicant Wampole Laboratories

K number K883004

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KTN 1988-04-07

MONO-PHILE

Applicant Bio Diagnostic Systems, Inc.

K number K881247

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KTN 1988-02-17

V-TREND IM DRY-SPOT TEST

Applicant Texas Immunology, Inc.

K number K880399

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KTN 1988-02-10

INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST

Applicant Ampcor, Inc.

K number K880148

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KTN 1987-12-14

I.M.N. LATEX

Applicant Biokit USA, Inc.

K number K874678

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KTN 1987-12-14

DIFFERENTIAL I.M. SCREENING TEST

Applicant Sclavo, Inc.

K number K873297

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KTN 1987-06-29

VENTRESCREEN (TM) MONO

Applicant Ventrex Laboratories, Inc.

K number K872032

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KTN 1986-12-03

DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO

Applicant Gamma Biologicals, Inc.

K number K864207

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KTN 1986-07-03

MONO-LATEX (TM) SLIDE TEST

Applicant Armkel, LLC

K number K862008

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KTN 1986-05-13

MONOSTAR SYSTEM: IM LATEX TEST

Applicant U.S. Health Resources Corp.

K number K861452

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KTN 1986-04-18

GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS

Applicant Gamma Biologicals, Inc.

K number K861016

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KTN 1985-10-16

CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036

Applicant Preco, Inc.

K number K853144

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KTN 1985-09-03

IMMUNO-IM

Applicant Immunostics Co., Inc.

K number K853105

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KTN 1985-08-22

MONOSTICON UNI-DOT

Applicant Organon, Inc.

K number K853388

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KTN 1984-11-19

SERIES I/S INFECTIONS

Applicant American Dade

K number K844289

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KTN 1984-06-13

MONO-TEC

Applicant Medilab Corp.

K number K841863

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KTN 1984-04-05

LEAP MONO TEST KIT

Applicant Cooper Biomedical, Inc.

K number K840822

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KTN 1984-02-10

IM-CHECK

Applicant Diagnostic Technology, Inc.

K number K834345

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KTN 1983-03-17

MONO SCREENING TEST

Applicant Tago, Inc.

K number K830531

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KTN 1982-07-02

SERO/TEX MONO TEST

Applicant Texas Immunology, Inc.

K number K821386

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KTN 1981-09-24

CORDIA IM

Applicant Cordis Corp.

K number K812540

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KTN 1979-12-31

AGGLUTINOTEST-INFECTIOUS MONONUCLEOSIS

Applicant Volu Sol Medical Industries

K number K791455

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KTN 1977-08-22

MONOSTICON TEST

Applicant Organon, Inc.

K number K771397

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KTN 1976-08-03

TEST, MONO., CARD (MACRO-VUE)

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K760040

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