Product Code: NSU


Products Classified as NSU

639Instrumentation For Clinical Multiplex Test SystemsInstrumentation For Clinical Multiplex Test Systems.

Total Product Life Cycle (TPLC) Devices

639Instrumentation For Clinical Multiplex Test SystemsInstrumentation For Clinical Multiplex Test Systems.

Pre-market Notifications for NSU

K163652EPlex InstrumentGenMark Diagnostics, Incorporated
BK150270510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices BioArray Solutions, Ltd.
K143178FilmArray 2.0 SystemBioFire Diagnostics, LLC
K141220APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARETHERMO FISHER SCIENTIFIC (LIFE TECHNOLOGIES HOLDIN
BK140112510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Bio-Rad Laboratories
K133849VANTERA CLINICAL ANALYZERLIPOSCIENCE
K133302FLEXMAP 3DLUMINEX CORP.
BK130051510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices BioArray Solutions, Ltd.
K121399LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD PLUMINEX CORP.
K110786ESENSOR WARFARIN SENSITIVITY SALIVA TESTGENMARK DIAGNOSTICS, INC
K093128ILLUMINA BEADXPRESS SYSTEMILLUMINA, INC.
K082562APPLIED BIOSYSTEMS 7500 FAST DXAPPLIED BIOSYSTEMS INC
K080995MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEMAffymetrix, Inc.
K073506LUMINEX LX 100/200 INSTRUMENTLUMINEX CORP.
K070597VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TESTNANOSPHERE, INC

Global Unique Device Identification Database

00382904437121Instrumentation For Clinical Multiplex Test Systems
00628055420101Instrumentation For Clinical Multiplex Test Systems
00628055420095Instrumentation For Clinical Multiplex Test Systems
00628055420088Instrumentation For Clinical Multiplex Test Systems
00628055420071Instrumentation For Clinical Multiplex Test Systems
00628055420064Instrumentation For Clinical Multiplex Test Systems
00628055420057Instrumentation For Clinical Multiplex Test Systems
00628055420040Instrumentation For Clinical Multiplex Test Systems
00628055420033Instrumentation For Clinical Multiplex Test Systems
00628055420026Instrumentation For Clinical Multiplex Test Systems
00628055420019Instrumentation For Clinical Multiplex Test Systems
00814695022588Instrumentation For Clinical Multiplex Test Systems
00812117015699Instrumentation For Clinical Multiplex Test Systems
00815381020291Instrumentation For Clinical Multiplex Test Systems
00815381020284Instrumentation For Clinical Multiplex Test Systems

Maude Adverse Events

BIOPLEX 2200BIO-RAD LABORATORIES, INC2017-12-13
PANTHER SYSTEMHOLOGIC INCORPORATED2017-09-25
FILMARRAY?BIOMERIEUX, INC.2017-02-08
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE LTD.2016-05-10
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE LTD.2016-02-18
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE LTD.2016-01-11
VANTERA CLINICAL ANALYZERLIPOSCIENCE INC2015-02-13
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCRLIFE TECHNOLOGIES HOLDING PTE. LTD.2015-01-10
ONCOTYPE DX FOR NODE POSITIVE BREAST CANCERGENOMIC HEALTH2014-09-22
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE. LTD.2014-06-27
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE. LTD.2014-06-27
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE. LTD.2014-06-27
APPLIED BIOSYSTEM 7500 FAST DX REAL-TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE. LTD.2014-06-27
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE. LTD.2014-06-27
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE. LTD.2014-06-27
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE. LTD.2014-06-27
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE. LTD.2014-06-27
APPLIED BIOSYSTEMS 7500 FAST DX REAL TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE. LTD.2014-06-27
APPLIED BIIOSYSTEMS 7500 FAST DX REAL-TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE LTD2014-06-27
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE. LTD.2014-06-27
APPLIED BIOSYSTEMS 7500 FAST DX REAL TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE LTD2014-06-27
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE. LTD.2014-06-27
APPLIED BIOSYSTEMS 7500 FAST DX REAL TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE. LTD.2014-06-27
APPLIED BIOSYSTEMS 7500 FAST DX REAK TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE LTD2014-06-27
APPLIED BIOSYSTEMS 7500 FAST DX REAL TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE. LTD.2014-06-27
APPLIED BIOSYSTEMS 7500 FAST DX REAL TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE. LTD.2014-06-27
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCRLIFE TECHNOLOGIES HOLDINIGS PTE., LTD.2014-06-27
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE. LTD,2014-06-27
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE. LTD.2014-06-27
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE. LTD.2014-06-27
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE. LTD.2014-06-27
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE LTD2014-06-27
7500 FAST DX REAL-TIME PCR INSTRUMENTLIFE TECHNOLOGIES HOLDINGS PTE LTD2014-06-11
VERITI DX THERMAL CYCLERLIFE TECHNOLOGIES HOLDINGS PTE. LTD.2014-03-25
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE. LTD.2014-03-14
VERITI DX THERMAL CYCLERLIFE TECHNOLOGIES HOLDING PTE. LTD2014-03-06
APPLIED BIOSYSTEMS 7500 FAST X REAL-TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE. LTD.2014-02-27
VERITI DX THERMAL CYCLERLIFE TECHNOLOGIES HOLDINGS PTE. LTD.2014-01-15
VERITI DX THERMAL CYCLERLIFE TECHNOLOGIES HOLDINGS PTE. LTD2013-12-23
APPLIED BIOSYSTEMS 7500 FAST FX REAL-TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE. LTD.2013-12-09
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE. LTD.2013-12-09
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE. LTD.2013-12-09
VERITI DX THERMAL CYCLERLIFE TECHNOLOGIES HOLDINGS PTE. LTD.2013-12-09
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE. LTD.2013-12-09
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE. LTD.2013-12-09
APPLIED BIOSYSTEMS 7500 FAST DX REAL TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE LTD2013-12-09
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE. LTD.2013-12-09
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE. LTD.2013-12-09
APPLIED BIOSYSTEMS 7500 FAST DX REAL TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE LTD2013-12-09
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCRLIFE TECHNOLOGIES HOLDINGS PTE. LTD.2013-12-09

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