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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 - 00812242030536

JCV Low Run Control
EXACT DIAGNOSTICS, LLC
JCVL101
In Commercial Distribution

  • 00812242030536 ()
JCVL101

  • JC virus (JCV) nucleic acid IVD, control

Exact Diagnostics - 00812242030529

JCV Verification Panel
EXACT DIAGNOSTICS, LLC
JCVP100
In Commercial Distribution

  • 00812242030529 ()
JCVP100

  • JC virus (JCV) nucleic acid IVD, calibrator

Exact Diagnostics - 00812242030505

Enterovirus Run Control
EXACT DIAGNOSTICS, LLC
EVRC
In Commercial Distribution

  • 00812242030505 ()
EVRC

  • Multiple-type meningitis-associated microorganism nucleic acid IVD, control

Exact Diagnostics - 00812242030499

Parvovirus B19 High Run Control
EXACT DIAGNOSTICS, LLC
B19H102
In Commercial Distribution

  • 00812242030499 ()
B19H102

  • Parvovirus B19 nucleic acid IVD, control

Exact Diagnostics - 00812242030482

Parvovirus B19 Low Run Control
EXACT DIAGNOSTICS, LLC
B19L101
In Commercial Distribution

  • 00812242030482 ()
B19L101

  • Parvovirus B19 nucleic acid IVD, control

Exact Diagnostics - 00812242030475

Parvovirus B19 Verification Panel
EXACT DIAGNOSTICS, LLC
B19P100
In Commercial Distribution

  • 00812242030475 ()
B19P100

  • Parvovirus B19 nucleic acid 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

Exact Diagnostics - 00812242030383

HHV-6B Verification Panel
EXACT DIAGNOSTICS, LLC
HV6BP100
In Commercial Distribution

  • 00812242030383 ()
HV6BP100

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

Exact Diagnostics - 00812242030376

HHV-6A Verification Panel
EXACT DIAGNOSTICS, LLC
HV6AP100
In Commercial Distribution

  • 00812242030376 ()
HV6AP100

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

Exact Diagnostics - 00812242030369

VZV High Run Control
EXACT DIAGNOSTICS, LLC
VZVH102
In Commercial Distribution

  • 00812242030369 ()
VZVH102

  • Varicella-zoster virus (VZV) nucleic acid IVD, control

Exact Diagnostics - 00812242030352

VZV Low Run Control
EXACT DIAGNOSTICS, LLC
VZVL101
In Commercial Distribution

  • 00812242030352 ()
VZVL101

  • Varicella-zoster virus (VZV) nucleic acid IVD, control

Exact Diagnostics - 00812242030345

VZV Verification Panel
EXACT DIAGNOSTICS, LLC
VZVP100
In Commercial Distribution

  • 00812242030345 ()
VZVP100

  • Varicella-zoster virus (VZV) nucleic acid IVD, calibrator

Exact Diagnostics - 00812242030338

Adenovirus High Run Control
EXACT DIAGNOSTICS, LLC
ADVH102
In Commercial Distribution

  • 00812242030338 ()
ADVH102

  • Adenovirus nucleic acid IVD, control
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