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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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Exact Diagnostics - 00812242030079

Bulk Negative
EXACT DIAGNOSTICS, LLC
NEG050
In Commercial Distribution

  • 00812242030079 ()
NEG050

  • PCR/NAT negative control IVD

Exact Diagnostics - 00812242030062

Negative Run Control
EXACT DIAGNOSTICS, LLC
NEG000
In Commercial Distribution

  • 00812242030062 ()
NEG000

  • PCR/NAT negative control IVD

Exact Diagnostics - 00812242030055

CMV High Run Control
EXACT DIAGNOSTICS, LLC
CMVH102
In Commercial Distribution

  • 00812242030055 ()
CMVH102

  • Cytomegalovirus (CMV) nucleic acid IVD, control

Exact Diagnostics - 00812242030048

CMV Low Run Control
EXACT DIAGNOSTICS, LLC
CMVL101
In Commercial Distribution

  • 00812242030048 ()
CMVL101

  • Cytomegalovirus (CMV) nucleic acid IVD, control

Exact Diagnostics - 00812242030024

HIV-1 High Run Control
EXACT DIAGNOSTICS, LLC
HIVH102
In Commercial Distribution

  • 00812242030024 ()
HIVH102

  • HIV1 nucleic acid IVD, control

Exact Diagnostics - 00812242030017

HIV-1 Low Run Control
EXACT DIAGNOSTICS, LLC
HIVL101
In Commercial Distribution

  • 00812242030017 ()
HIVL101

  • HIV1 nucleic acid IVD, control

Keratin 5 Polyclonal Chicken Antibody, Purified - 00810034700087

URL: https://www.biolegend.com/en-us/products/keratin-5-polyclonal-chicken-antibody-purified-10957
BIOLEGEND, INC.
905901
In Commercial Distribution

  • 00810034700087 ()

  • Total Volume: 100 Microliter
905901

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

Keratin 5 Polyclonal Antibody, Purified - 00810034700063

URL: https://www.biolegend.com/en-us/products/keratin-5-polyclonal-antibody-purified-10956
BIOLEGEND, INC.
905501
In Commercial Distribution

  • 00810034700063 ()

  • Total Volume: 100 Microliter
905501

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

Keratin 14 Polyclonal Antibody, Purified. - 00810034700049

URL: https://www.biolegend.com/en-us/products/keratin-14-polyclonal-antibody-purified-10953
BIOLEGEND, INC.
905301
In Commercial Distribution

  • 00810034700049 ()

  • Total Volume: 100 Microliter
905301

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

Hologic - 15420045506633

Universal General Purpose Reagent - Universal Arm6/Red FRET.
Hologic, Inc.
UNIVERSAL ARM6/RED FRET
Not in Commercial Distribution

  • 15420045506633 ()
96-016

  • Nucleic acid technique (NAT) chemiluminescent signal generation kit IVD
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