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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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Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens
LUMINEX CORPORATION
3906-21
Not in Commercial Distribution

  • 00840487101278 ()
3906-21

  • Cytomegalovirus (CMV) nucleic acid IVD, reagent
Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens
LUMINEX CORPORATION
3906
In Commercial Distribution

  • 00840487101261 ()
3906

  • Cytomegalovirus (CMV) nucleic acid IVD, reagent
Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens
LUMINEX CORPORATION
3903
In Commercial Distribution

  • 00840487101254 ()
3903

  • Enterovirus nucleic acid (serotypes 68-71) IVD, reagent
Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens
LUMINEX CORPORATION
3902
In Commercial Distribution

  • 00840487101247 ()
3902

  • Multiple Bordetella species nucleic acid IVD, reagent
Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens
LUMINEX CORPORATION
3901
In Commercial Distribution

  • 00840487101230 ()
3901

  • Bordetella pertussis nucleic acid IVD, reagent
Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens
LUMINEX CORPORATION
3900
In Commercial Distribution

  • 00840487101223 ()
3900

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, reagent
Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.
LUMINEX CORPORATION
3804-22
In Commercial Distribution

  • 00840487101216 ()
3804-22

  • Endogenous RNA internal control reagent IVD
Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.
LUMINEX CORPORATION
3804-21
Not in Commercial Distribution

  • 00840487101209 ()
3804-21

  • Endogenous RNA internal control reagent IVD
Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.
LUMINEX CORPORATION
3804
In Commercial Distribution

  • 00840487101193 ()
3804

  • Endogenous RNA internal control reagent IVD
Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.
LUMINEX CORPORATION
3803-21
In Commercial Distribution

  • 00840487101186 ()
3803-21

  • Endogenous RNA internal control reagent IVD
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