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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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iC-Processor - B769ICPADAAA0000

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

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

Silaris Dock - B54010260

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

Silaris Influenza A&B Control Kit - B54010240

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

GeneSTAT - A91004001

Automated PCR analyzer
DXNA LLC
91004001
In Commercial Distribution

  • A91004001 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

BD PCR Cartridge - 30382904375196

BD PCR Cartridges 24EA
BECTON, DICKINSON AND COMPANY
437519
In Commercial Distribution

  • 30382904375196 ()
  • 00382904375195 ()
437519

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Savanna - 30014613340089

Savanna Instrument
DIAGNOSTIC HYBRIDS, INC.
20382R
In Commercial Distribution

  • 30014613340089 ()
20382R

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

Savanna - 30014613339304

Savanna Instrument
DIAGNOSTIC HYBRIDS, INC.
20382
In Commercial Distribution

  • 30014613339304 ()
20382

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