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

  • 04260364750003 ()
60001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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
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
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
The Silaris Dock is an electronic module which executes in vitro diagnostic tests on compatible Silaris 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.
1026
In Commercial Distribution

  • B54010260 ()
1026

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
The Silaris™ Influenza A&B Control Kit is intended for in vitro diagnostic use in quality control testing with the Silaris™ Influenza A&B Test.
MESA BIOTECH, INC.
1024
In Commercial Distribution

  • B54010240 ()
1024

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
The iC-System is an in vitro diagnostic device designed to perform multiplex amplification for the detection and identification of assay-specific targets.
ICUBATE, INC
iCR-ADAA00000
In Commercial Distribution

  • B769ICRADAA00000 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
The iC-System is an in vitro diagnostic device designed to perform multiplex amplification for the detection and identification of assay-specific targets.
ICUBATE, INC
iCP-ADAAA0000
In Commercial Distribution

  • B769ICPADAAA0000 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
CFX Opus Deepwell Dx
BIO-RAD LABORATORIES, INC.
12016687
In Commercial Distribution

  • 03610522260829 ()

  • 1 ea
12016687

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
CFX Opus 384 Dx
BIO-RAD LABORATORIES, INC.
12014335
In Commercial Distribution

  • 03610522203437 ()

  • 1 each
12014335

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
CFX Opus 96 Dx
BIO-RAD LABORATORIES, INC.
12014330
In Commercial Distribution

  • 03610522203413 ()

  • 1 each
12014330

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
CFX96 Dx and CFX96 Deep Well Dx Systems
BIO-RAD LABORATORIES, INC.
1844095-IVD
In Commercial Distribution

  • 03610520550984 ()
1844095-IVD

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
CFX96 Dx and CFX96 Deep Well Dx Systems
BIO-RAD LABORATORIES, INC.
1845097-IVD
In Commercial Distribution

  • 03610520457818 ()
1845097-IVD

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
DIASORIN MOLECULAR LLC
MOL1011
In Commercial Distribution

  • 10816101025029 ()
MOL1011

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
DIASORIN MOLECULAR LLC
MOL1001-P
In Commercial Distribution

  • 10816101025012 ()
MOL1001-P

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
DIASORIN MOLECULAR LLC
MOL1001
In Commercial Distribution

  • 10816101025005 ()
MOL1001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
NeuMoDx™ 96 Molecular System
Neumodx Molecular, Inc.
500200
In Commercial Distribution

  • 00814278020000 ()
  • 10814278020724 ()

  • Width: 137.2 Centimeter
  • Height: 109.2 Centimeter
  • Depth: 109.2 Centimeter
500200

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
A55826
In Commercial Distribution

  • 10190302018944 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
LIFE TECHNOLOGIES CORPORATION
A54626
In Commercial Distribution

  • 10190302018449 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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