KTN

Product Code: KTN


Products Classified as KTN

3025System, Test, Infectious MononucleosisInfectious Mononucleosis Immunological Test System.

Total Product Life Cycle (TPLC) Devices

3025System, Test, Infectious MononucleosisInfectious Mononucleosis Immunological Test System.

Pre-market Notifications for KTN

K181436OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid TestSekisui Diagnostics, LLC
K042272ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)ACON LABORATORIES, INC.
K030215BIORAPID MONONUCLEOSISINSTRUMENTATION LABORATORY CO.
K012901COLOR-MONOGENINSTRUMENTATION LABORATORY CO.
K982634DRYSPOT INFECTIOUS MONONUCLEOSIS KITOXOID, LTD.
K981946CLEARVIEW IMUNIPATH LTD.
K972457MONOCOL/LEX-IM TESTIMMUNOSTICS, INC.
K972231OSOM MONO TEST 143WYNTEK DIAGNOSTICS, INC.
K963425GENZYME DIAGNOSTICS CONTRAST MONOGENZYME DIAGNOSTICS
K961550QUALITROL MONO CONTROL SERUM SETCONSOLIDATED TECHNOLOGIES, INC.
K961024BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WBPRINCETON BIOMEDITECH CORP.
K932688EYE SPOT IM TESTJ.S. MEDICAL ASSOC.
K932551ACCUTEX IM LATEX TESTJ.S. MEDICAL ASSOC.
K930778IMMUNOCARD MONOMERIDIAN DIAGNOSTICS, INC.
K925183BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TESTPRINCETON BIOMEDIX

Global Unique Device Identification Database

00304040001387SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS
00613647001325SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS
00613647001318SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS
00613647001301SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS
00613647001202SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS
00613647001196SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS
20613647000285SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS
00695684770259System, Test, Infectious Mononucleosis
00657498000038System, Test, Infectious Mononucleosis
00742860100048SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS
00742860001451SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS
00722066000311System, Test, Infectious Mononucleosis
00816917021546System, Test, Infectious Mononucleosis
00816057021611System, Test, Infectious Mononucleosis
00816057020324System, Test, Infectious Mononucleosis

Maude Adverse Events

HENRY SCHEIN MONO TEST DEVICE 20TALERE SAN DIEGO2020-03-31
ACCEAVA MONO TEST STRIP 25T (92404)ALERE SAN DIEGO, INC.2020-02-06
CLARITY MONO TESTCLARITY DIAGNOSTICS LLC2019-11-20
CLARITY MONONUCLEOSIS RAPID TEST CASSETTECLARITY DIAGNOSTICS LLC2019-11-20
ICON MONO RAPID HETEROPHILE ANTIBODY TESTBECKMAN COULTER, INC.2008-12-23
ICON MONO IMMUNOCHEMICAL ANTIGEN TESTBECKMAN COULTER, INC.2008-05-20
OXOIDOXOID LTD., C/O LIFESIGN2004-08-27
MONO-PLUS QUALITATIVE ASSAYPRINCETON BIOMEDICAL2002-06-27
RUSSELL-TAYLOR NAILSMITH AND NEPHEW RICHARDS1994-01-14
CONCISE MONO TESTHYBRITECH, INC.1993-05-18

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