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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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Millennium - 00190776158033

Brackman Suction Tube, 7fr, 5" working length (single barrel - Poole Suction)
Avalign Technologies, Inc.
72-SM367FR5
In Commercial Distribution

  • 00190776158033 ()


  • B-cell acute lymphoblastic leukaemia (B-ALL) genetic mutation IVD, kit, nucleic acid technique (NAT)

Millennium - 00190776158026

Special Made ENT suction Tip for use with 72-SM240221CH01
Avalign Technologies, Inc.
72-SM240221CH02
In Commercial Distribution

  • 00190776158026 ()


  • B-cell acute lymphoblastic leukaemia (B-ALL) genetic mutation IVD, kit, nucleic acid technique (NAT)

Millennium - 00190776158019

Special Made ENT Suction Handle
Avalign Technologies, Inc.
72-SM240221CH01
In Commercial Distribution

  • 00190776158019 ()


  • B-cell acute lymphoblastic leukaemia (B-ALL) genetic mutation IVD, kit, nucleic acid technique (NAT)

Dermatophyte and C. albicans Real Time PCR kit - 05713106994627

Intended use The Dermatophyte and C. albicans Real Time PCR Kit is an in vitro diagnostic kit for the quantitative detection of general dermatophytes (pan-dermatophytes), Trichophyton (T.) rubrum and Candida (C.) albicans in nail, skin, and hair specimens.
Ssi Diagnostica A/S
99462
In Commercial Distribution

  • 05713106994627 ()
99462

  • Multiple dermatophyte species nucleic acid IVD, kit, nucleic acid technique (NAT)

Trinity Biotech - 05391516748889

Trypanosoma cruzi 12 well slide, 8 each pack
MARDX DIAGNOSTICS, INC.
20-03012
In Commercial Distribution

  • 05391516748889 ()
20-03012

  • Trypanosoma cruzi total antibody IVD, kit, fluorescent immunoassay

Trinity Biotech - 05391516748872

FITC Parasite IgG Conjugate (Rodent), 4.0 mL
MARDX DIAGNOSTICS, INC.
20-90215
In Commercial Distribution

  • 05391516748872 ()
20-90215

  • Trypanosoma cruzi immunoglobulin G (IgG)/IgM antibody IVD, reagent

Trinity Biotech - 05391516748865

Trypanosoma cruzi 6 Well Slide, 8 each pack
MARDX DIAGNOSTICS, INC.
20-03006
In Commercial Distribution

  • 05391516748865 ()
20-03006

  • Trypanosoma cruzi total antibody IVD, kit, fluorescent immunoassay

Trinity Biotech - 05391516748681

Trypanosomiasis IFA Test System, 48 Tests
MARDX DIAGNOSTICS, INC.
20-03648
In Commercial Distribution

  • 05391516748681 ()
20-03648

  • Trypanosoma cruzi total antibody IVD, kit, fluorescent immunoassay

LeukoStrat - 00810022732571

The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia (AML).
INVIVOSCRIBE, INC.
00810022732571
In Commercial Distribution

  • 00810022732571 ()
K4120361

  • Acute myeloid leukaemia (AML) genetic mutation IVD, kit, nucleic acid technique (NAT)

LeukoStrat - 00850052003739

The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia (AML).
INVIVOSCRIBE, INC.
850052003739
Not in Commercial Distribution

  • 00850052003739 ()
K4120361

  • Acute myeloid leukaemia (AML) genetic mutation IVD, kit, nucleic acid technique (NAT)
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