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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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CytoCell myProbes - 05055844911550

FLT3 Distal in FITC Spectrum
CYTOCELL LIMITED
MPH26332
In Commercial Distribution

  • 05055844911550 ()


  • Assay development analyte-specific reagent IVD

CytoCell myProbes - 05055844911543

FLT3 Proximal in Texas Red Spectrum
CYTOCELL LIMITED
MPH26331
In Commercial Distribution

  • 05055844911543 ()


  • Assay development analyte-specific reagent IVD

CytoCell myProbes - 05055844911536

EBF1 Distal in Texas Red Spectrum
CYTOCELL LIMITED
MPH2572
In Commercial Distribution

  • 05055844911536 ()


  • Assay development analyte-specific reagent IVD

CytoCell myProbes - 05055844911512

CCND3 in Aqua Spectrum
CYTOCELL LIMITED
MPH2563
In Commercial Distribution

  • 05055844911512 ()


  • Assay development analyte-specific reagent IVD

CytoCell myProbes - 05055844911406

IGL in FITC Spectrum
CYTOCELL LIMITED
MPH24612
In Commercial Distribution

  • 05055844911406 ()


  • Assay development analyte-specific reagent IVD

CytoCell myProbes - 05055844911383

CBFB Distal in FITC Spectrum
CYTOCELL LIMITED
MPH2392
In Commercial Distribution

  • 05055844911383 ()


  • Assay development analyte-specific reagent IVD

CytoCell myProbes - 05055844911369

ABL1 Fast Probe in FITC Spectrum
CYTOCELL LIMITED
MPH23392
In Commercial Distribution

  • 05055844911369 ()


  • Assay development analyte-specific reagent IVD

CytoCell myProbes - 05055844911352

BCR Fast Probe in Texas Red Spectrum
CYTOCELL LIMITED
MPH23391
In Commercial Distribution

  • 05055844911352 ()


  • Assay development analyte-specific reagent IVD

EasyScreen™ Gastrointestinal Parasite PCR Positive Control - 09351179004070

The EasyScreen™ Gastrointestinal Parasite PCR Positive Control (PC-PROT-001) is a control material for nucleic acid testing of patient clinical samples. It is designed to provide a positive PCR signal for each of the protozoan targets in the EasyScreen™ Gastrointestinal Parasite Detection Kit (EP005). The Positive Control does not require processing and is designed to be added directly to the PCR mastermix when a positive signal in all detection channels is required for quality control purposes. This Positive Control demonstrates that all PCR targets are being detected as expected, and does not provide any results from clinical specimens. This Positive Control is for Investigational in vitro Diagnostic (IVD) Use Only in hospital and pathology laboratories or similar, by trained personnel.
GENETIC SIGNATURES LIMITED
1
In Commercial Distribution

  • 09351179004070 ()
PC-PROT-001

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

EasyScreen™ Gastrointestinal Parasite Detection Kit - 09351179001161

The EasyScreen™ Gastrointestinal Parasite Detection Kit is intended for use as an aid in the diagnosis of gastrointestinal illness by qualitative detection of Gastrointestinal Parasites from stool of patients with diarrhoea.
GENETIC SIGNATURES LIMITED
1
In Commercial Distribution

  • 09351179001161 ()
EP005-HT

  • Multiple faecal parasite nucleic acid IVD, kit, nucleic acid technique (NAT)
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