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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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Fungal Serology - 10634853000015

Blastomyces dermatitidis Antigen (A), 1mL
MICROBIOLOGICS INC.
200125
Not in Commercial Distribution

  • 10634853000015 ()
200125

  • Blastomyces dermatitidis total antibody IVD, control

MassTrak™ - 00816776020001

Waters® MassTrak™ Immunosuppressants Kit
WATERS TECHNOLOGIES CORPORATION
186002891
In Commercial Distribution

  • 00816776020001 ()
186002891

  • Tacrolimus therapeutic drug monitoring IVD, control
  • Tacrolimus therapeutic drug monitoring IVD, calibrator

Exact Diagnostics - 00812242030468

HSV-2 High Run Control
EXACT DIAGNOSTICS, LLC
HSV2H102
In Commercial Distribution

  • 00812242030468 ()
HSV2H102

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

Exact Diagnostics - 00812242030451

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

Exact Diagnostics - 00812242030444

HSV-2 Verification Panel
EXACT DIAGNOSTICS, LLC
HSV2P100
In Commercial Distribution

  • 00812242030444 ()
HSV2P100

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

Exact Diagnostics - 00812242030437

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

Exact Diagnostics - 00812242030420

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

Exact Diagnostics - 00812242030413

HSV-1 Verification Panel
EXACT DIAGNOSTICS, LLC
HSV1P100
In Commercial Distribution

  • 00812242030413 ()
HSV1P100

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

Exact Diagnostics - 00812242030406

HHV-6 High Run Control
EXACT DIAGNOSTICS, LLC
HV6H102
In Commercial Distribution

  • 00812242030406 ()
HV6H102

  • Human herpesvirus 6 (HHV6) nucleic acid IVD, control

Exact Diagnostics - 00812242030390

HHV-6 Low Run Control
EXACT DIAGNOSTICS, LLC
HV6L101
In Commercial Distribution

  • 00812242030390 ()
HV6L101

  • Human herpesvirus 6 (HHV6) nucleic acid IVD, control
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