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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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HSV-2 Low Run Control
EXACT DIAGNOSTICS, LLC
HSV2L101
In Commercial Distribution

  • 00812242030451 ()
HSV2L101

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
HSV-2 Verification Panel
EXACT DIAGNOSTICS, LLC
HSV2P100
In Commercial Distribution

  • 00812242030444 ()
HSV2P100

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, calibrator
HSV-1 High Run Control
EXACT DIAGNOSTICS, LLC
HSV1H102
In Commercial Distribution

  • 00812242030437 ()
HSV1H102

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
HSV-1 Low Run Control
EXACT DIAGNOSTICS, LLC
HSV1L101
In Commercial Distribution

  • 00812242030420 ()
HSV1L101

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
HSV-1 Verification Panel
EXACT DIAGNOSTICS, LLC
HSV1P100
In Commercial Distribution

  • 00812242030413 ()
HSV1P100

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, calibrator
The Alethia™ HSV 1&2 External Control Kit contains Positive and Negative Control Reagents for use with the illumigene HSV 1&2 DNA Amplification Assay. External controls are used as part of a routine quality control program.
MERIDIAN BIOSCIENCE, INC.
479960
In Commercial Distribution

  • 00840733102158 ()
479960

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
The illumigene HSV 1&2 External Control Kit contains Positive and Negative Control Reagents for use with the illumigene HSV 1&2 DNA Amplification Assay. External controls are used as part of a routine quality control program.
MERIDIAN BIOSCIENCE, INC.
279960
Not in Commercial Distribution

  • 00840733101151 ()
279960

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
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
No Description
QIAGEN GmbH
1
In Commercial Distribution

  • 04053228004417 ()
1066155

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, reagent
No Description
QIAGEN GmbH
1
In Commercial Distribution

  • 04053228004387 ()
1066176

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
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