Real Time Nucleic Acid Amplification System

Product Code: OOI

Clinical Chemistry In Vitro And Other Medical Laser Products

Definition: The System Is A Clinical Multiplex Instrument Intended To Measure And Sort Multiple Signals Generated My Multiple Probes, Intercalating Dyes, Or Other Ligands In An Assay From A Clinical Sample. Signals May Be Generated By Fluorescence Or Other Phenomena And May Be Measured Using Filters On A Photodiode Or Other Detector. It May Integrate Sample An

Applicable Standards: Laser Products. [1040.10]

Code of Federal Regulations: 862.2570


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as OOI

645Real Time Nucleic Acid Amplification SystemInstrumentation For Clinical Multiplex Test Systems.

Total Product Life Cycle (TPLC) Devices

645Real Time Nucleic Acid Amplification SystemInstrumentation For Clinical Multiplex Test Systems.

Pre-market Notifications for OOI

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K123955QUANTSTUDIO DX REAL-TIME PCR INSTRUMENTLIFE TECHNOLOGIES CORPORATION
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K1023143M INTEGRATED CYCLER (110V) & (220V)FOCUS DIAGNOSTICS, INC.
K093383NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAGBIOMERIEUX, INC.
K092705ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501ABBOTT MOLECULAR, INC.

Global Unique Device Identification Database

00382904434199real time Nucleic acid amplification system
00382904429584real time Nucleic acid amplification system
00382904429508real time Nucleic acid amplification system
00382904428396real time Nucleic acid amplification system
00382904419271real time Nucleic acid amplification system
00382904419165real time Nucleic acid amplification system
00628055344032Real Time Nucleic Acid Amplification System
00628055344001Real Time Nucleic Acid Amplification System
00815381020307Real Time Nucleic Acid Amplification System
00815381020093Real Time Nucleic Acid Amplification System
00815381020086Real Time Nucleic Acid Amplification System
00884999043503real time Nucleic acid amplification system
00884999043497real time Nucleic acid amplification system
00884999031814real time Nucleic acid amplification system
00884999006539real time Nucleic acid amplification system

Maude Adverse Events

ID NOW INSTRUMENTABBOTT DIAGNOSTICS SCARBOROUGH, INC.2020-01-15
BD MAX? INSTRUMENTBECTON, DICKINSON & CO.2019-10-22
ABBOTT M2000SP INSTRUMENTABBOTT MOLECULAR, INC.2018-08-28
ABBOTT M2000RT INSTRUMENTABBOTT MOLECULAR, INC.2018-03-22
BD MAX? SYSTEMBECTON, DICKINSON & CO.2016-08-10
BD VIPER? LT SYSTEMBECTON, DICKINSON & CO.2016-01-05
BD VIPER? LT SYSTEMBECTON, DICKINSON & CO.2016-01-05
BD MAX? SYSTEMBECTON, DICKINSON & CO.2015-10-09
3M INTEGRATED CYCLERFOCUS DIAGNOSTICS, INC.2014-12-29
QUANTSTUDIO DX REAL-TIME PCR INSTRUMENTLIFE TECHNOLOGIES HOLDINGS PTE., LTD.2014-06-27
QUANTSTUDIO DX REAL-TIME PCR INSTRUMENTLIFE TECHNOLOGIES HOLDINGS PTE. LTD.2014-05-02
ABBOTT M2000RTABBOTT MOLECULAR, INC.2014-03-04
BD MAX INSTRUMENTBD DIAGNOSTIC SYSTEMS2014-01-06
BD MAX INSTRUMENTBD DIAGNOSTIC SYS2013-12-19
ABBOTT M2000RTABBOTT MOLECULAR, INC.2012-11-14
LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENTROCHE MOLECULAR SYSTEMS2012-07-11
ABBOTT M2000RTABBOTT MOLECULAR, INC.2012-05-01
ABBOTT M2000RTABBOTT MOLECULAR, INC.2011-11-29
LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENTROCHE MOLECULAR SYSTEMS2011-09-30
LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENTROCHE MOLECULAR SYSTEMS2011-09-07
ABBOTT M2000RTABBOTT MOLECULAR, INC.2011-04-29

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