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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 - 00812242030697

HBV 1E6 IU/mL Precision
EXACT DIAGNOSTICS, LLC
HBVH202
In Commercial Distribution

  • 00812242030697 ()
HBVH202

  • Hepatitis B virus nucleic acid IVD, calibrator

Exact Diagnostics - 00812242030680

HBV 1E3 IU/mL Precision
EXACT DIAGNOSTICS, LLC
HBVL201
In Commercial Distribution

  • 00812242030680 ()
HBVL201

  • Hepatitis B virus nucleic acid IVD, calibrator

Exact Diagnostics - 00812242030635

HCV Verification Panel 1.4mL
EXACT DIAGNOSTICS, LLC
HCVP200
In Commercial Distribution

  • 00812242030635 ()
HCVP200

  • Hepatitis C virus nucleic acid IVD, calibrator

Exact Diagnostics - 00812242030611

CMV 5E5 IU/mL Precision
EXACT DIAGNOSTICS, LLC
CMVH202
In Commercial Distribution

  • 00812242030611 ()
CMVH202

  • Cytomegalovirus (CMV) nucleic acid IVD, calibrator

Exact Diagnostics - 00812242030604

CMV 1E3 IU/mL Precision
EXACT DIAGNOSTICS, LLC
CMVL201
In Commercial Distribution

  • 00812242030604 ()
CMVL201

  • Cytomegalovirus (CMV) nucleic acid IVD, calibrator

Exact Diagnostics - 00812242030598

CMV Verification Panel 1.4mL
EXACT DIAGNOSTICS, LLC
CMVP200
In Commercial Distribution

  • 00812242030598 ()
CMVP200

  • Cytomegalovirus (CMV) nucleic acid IVD, calibrator

Exact Diagnostics - 00812242030574

HIV-1 1E5 cp/mL Precision
EXACT DIAGNOSTICS, LLC
HIVH202
In Commercial Distribution

  • 00812242030574 ()
HIVH202

  • HIV1 nucleic acid IVD, calibrator

Exact Diagnostics - 00812242030567

HIV-1 1E3 cp/mL Precision
EXACT DIAGNOSTICS, LLC
HIVL201
In Commercial Distribution

  • 00812242030567 ()
HIVL201

  • HIV1 nucleic acid IVD, calibrator

Exact Diagnostics - 00812242030550

HIV-1 Verification Panel 1.4mL
EXACT DIAGNOSTICS, LLC
HIVP200
In Commercial Distribution

  • 00812242030550 ()
HIVP200

  • HIV1 nucleic acid IVD, calibrator

Exact Diagnostics - 00812242030543

JCV High Run Control
EXACT DIAGNOSTICS, LLC
JCVH102
In Commercial Distribution

  • 00812242030543 ()
JCVH102

  • JC virus (JCV) nucleic acid IVD, control

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
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