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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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cobas Liat Analyzer Software 3.2 - 07613336148259

No Description
Roche Molecular Systems, Inc.
08276412001
In Commercial Distribution

  • 07613336148259 ()
08276412001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

cobas Liat System Software v3.1 Update Key for cobas Liat Analyzer - 07613336142738

No Description
Roche Molecular Systems, Inc.
08153248001
Not in Commercial Distribution

  • 07613336142738 ()
08153248001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

cobas Liat Advanced Tools Key - 07613336119570

No Description
Roche Molecular Systems, Inc.
07886985001
In Commercial Distribution

  • 07613336119570 ()
07886985001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

cobas Liat Software Version 3.0 - 07613336119563

No Description
Roche Molecular Systems, Inc.
07886977001
Not in Commercial Distribution

  • 07613336119563 ()
07886977001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

cobas Liat Analyzer - 07613336100097

No Description
Roche Molecular Systems, Inc.
07341920190
Not in Commercial Distribution

  • 07613336100097 ()
07341920190

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Acuitas - 04260364751017

QuantStudio Real-Time PCR Instrument qualified by Curetis for use with Acuitas AMR Gene Panel.
Curetis GmbH
Curetis Qualified QuantStudio™ 5 Real-Time PCR System
Not in Commercial Distribution

62006

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Unyvero - 04260364750003

Instrument to process 2 Unyvero Cartridges
Curetis GmbH
A50 Analyzer
Not in Commercial Distribution

  • 04260364750003 ()
60001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Accula Flu A / B Control Kit - B540FAB1100CWC0

The Accula™ Flu A / B Control Kit is intended for in vitro diagnostic use in quality control testing with the Accula™ Flu A / B Test.
MESA BIOTECH, INC.
FAB1100CW-C
In Commercial Distribution

  • B540FAB1100CWC0 ()
FAB1100CW-1

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care

Accula Programming Cassette - B540D20010

The Programming Cassette is an accessory to the Accula Dock and facilitates reprogramming of the Dock’s embedded firmware. When firmware updates are needed, the firmware will be stored onto Programming Cassettes and sent to end users, who will load the Programming Cassette into their Dock and re-program its firmware
MESA BIOTECH, INC.
D2001
In Commercial Distribution

  • B540D20010 ()
D2001

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care

Accula Dock - B540D20000

The Accula Dock is an electronic module which executes in vitro diagnostic tests on compatible Test Cassettes. It consists of an electro-mechanical interface to a single Test Cassette. The Dock contains all electrical systems, controls and logic necessary to orchestrate in-vitro diagnostic tests within the inserted Test Cassette.
MESA BIOTECH, INC.
D2000
In Commercial Distribution

  • B540D20000 ()
D2000

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
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