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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

Exact Diagnostics - 00812242030321

Adenovirus Low Run Control
EXACT DIAGNOSTICS, LLC
ADVL101
In Commercial Distribution

  • 00812242030321 ()
ADVL101

  • Adenovirus nucleic acid IVD, control

Exact Diagnostics - 00812242030314

Adenovirus Verification Panel
EXACT DIAGNOSTICS, LLC
ADVP100
In Commercial Distribution

  • 00812242030314 ()
ADVP100

  • Adenovirus nucleic acid IVD, calibrator

Exact Diagnostics - 00812242030222

HBV Analytical Measurement Range Panel
EXACT DIAGNOSTICS, LLC
HBVAMR
In Commercial Distribution

  • 00812242030222 ()
HBVAMR

  • Hepatitis B virus nucleic acid IVD, calibrator

Exact Diagnostics - 00812242030215

HCV Analytical Measurement Range Panel
EXACT DIAGNOSTICS, LLC
HCVAMR
In Commercial Distribution

  • 00812242030215 ()
HCVAMR

  • Hepatitis C virus nucleic acid IVD, calibrator

Exact Diagnostics - 00812242030208

HIV-1 Analytical Measurement Range Panel
EXACT DIAGNOSTICS, LLC
HIVAMR
In Commercial Distribution

  • 00812242030208 ()
HIVAMR

  • HIV1 nucleic acid IVD, calibrator

Exact Diagnostics - 00812242030192

BKV High Run Control
EXACT DIAGNOSTICS, LLC
BKVH102
In Commercial Distribution

  • 00812242030192 ()
BKVH102

  • BK virus (BKV) nucleic acid IVD, control

Exact Diagnostics - 00812242030185

BKV Low Run Control
EXACT DIAGNOSTICS, LLC
BKVL101
In Commercial Distribution

  • 00812242030185 ()
BKVL101

  • BK virus (BKV) nucleic acid IVD, control

Exact Diagnostics - 00812242030178

BKV Verification Panel
EXACT DIAGNOSTICS, LLC
BKVP100
In Commercial Distribution

  • 00812242030178 ()
BKVP100

  • BK virus (BKV) nucleic acid IVD, calibrator

Exact Diagnostics - 00812242030161

EBV High Run Control
EXACT DIAGNOSTICS, LLC
EBVH102
In Commercial Distribution

  • 00812242030161 ()
EBVH102

  • Epstein-Barr virus (EBV) nucleic acid IVD, control

Exact Diagnostics - 00812242030154

EBV Low Run Control
EXACT DIAGNOSTICS, LLC
EBVL101
In Commercial Distribution

  • 00812242030154 ()
EBVL101

  • Epstein-Barr virus (EBV) nucleic acid IVD, control

Exact Diagnostics - 00812242030147

EBV Verification Panel
EXACT DIAGNOSTICS, LLC
EBVP100
In Commercial Distribution

  • 00812242030147 ()
EBVP100

  • Epstein-Barr virus (EBV) nucleic acid IVD, calibrator

Exact Diagnostics - 00812242030130

HBV High Run Control
EXACT DIAGNOSTICS, LLC
HBVH102
In Commercial Distribution

  • 00812242030130 ()
HBVH102

  • Hepatitis B virus nucleic acid IVD, control

Exact Diagnostics - 00812242030123

HBV Low Run Control
EXACT DIAGNOSTICS, LLC
HBVL101
In Commercial Distribution

  • 00812242030123 ()
HBVL101

  • Hepatitis B virus nucleic acid IVD, control

Exact Diagnostics - 00812242030116

HBV Verification Panel
EXACT DIAGNOSTICS, LLC
HBVP100
In Commercial Distribution

  • 00812242030116 ()
HBVP100

  • Hepatitis B virus nucleic acid IVD, calibrator

Exact Diagnostics - 00812242030109

HCV High Run Control
EXACT DIAGNOSTICS, LLC
HCVH102
In Commercial Distribution

  • 00812242030109 ()
HCVH102

  • Hepatitis C virus nucleic acid IVD, control

Exact Diagnostics - 00812242030093

HCV Low Run Control
EXACT DIAGNOSTICS, LLC
HCVL101
In Commercial Distribution

  • 00812242030093 ()
HCVL101

  • Hepatitis C virus nucleic acid IVD, control

Exact Diagnostics - 00812242030086

HCV Verification Panel
EXACT DIAGNOSTICS, LLC
HCVP100
In Commercial Distribution

  • 00812242030086 ()
HCVP100

  • Hepatitis C virus nucleic acid IVD, calibrator

Exact Diagnostics - 00812242030079

Bulk Negative
EXACT DIAGNOSTICS, LLC
NEG050
In Commercial Distribution

  • 00812242030079 ()
NEG050

  • PCR/NAT negative control IVD

Exact Diagnostics - 00812242030062

Negative Run Control
EXACT DIAGNOSTICS, LLC
NEG000
In Commercial Distribution

  • 00812242030062 ()
NEG000

  • PCR/NAT negative control IVD

Exact Diagnostics - 00812242030055

CMV High Run Control
EXACT DIAGNOSTICS, LLC
CMVH102
In Commercial Distribution

  • 00812242030055 ()
CMVH102

  • Cytomegalovirus (CMV) nucleic acid IVD, control

Exact Diagnostics - 00812242030048

CMV Low Run Control
EXACT DIAGNOSTICS, LLC
CMVL101
In Commercial Distribution

  • 00812242030048 ()
CMVL101

  • Cytomegalovirus (CMV) nucleic acid IVD, control

Exact Diagnostics - 00812242030031

CMV Verification Panel
EXACT DIAGNOSTICS, LLC
CMVP100
In Commercial Distribution

  • 00812242030031 ()
CMVP100

  • Cytomegalovirus (CMV) nucleic acid IVD, calibrator

Exact Diagnostics - 00812242030024

HIV-1 High Run Control
EXACT DIAGNOSTICS, LLC
HIVH102
In Commercial Distribution

  • 00812242030024 ()
HIVH102

  • HIV1 nucleic acid IVD, control

Exact Diagnostics - 00812242030017

HIV-1 Low Run Control
EXACT DIAGNOSTICS, LLC
HIVL101
In Commercial Distribution

  • 00812242030017 ()
HIVL101

  • HIV1 nucleic acid IVD, control

Exact Diagnostics - 00812242030000

HIV-1 Verification Panel
EXACT DIAGNOSTICS, LLC
HIVP100
In Commercial Distribution

  • 00812242030000 ()
HIVP100

  • HIV1 nucleic acid IVD, calibrator

MedTest DX HCG Control Set Level B - 00817439020857

HCG Control Set Level B, for In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is intended for determining “Hook-Dose Effect” and the accuracy and precision of dilution protocols. Size: 4 x 2.5 ml
Medtest Dx, Inc.
HCG-CTLB
In Commercial Distribution

  • 00817439020857 ()
HCG-CTLB

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control

MedTest DX Elevated HCG Control Vial Label - B - 00817439020840

Elevated HCG Control Vial Label - B, For In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is intended for determining “Hook-Dose Effect” and the accuracy and precision of dilution protocols. Size: 1 x 2.5 mL.
Medtest Dx, Inc.
HCGCTLB
In Commercial Distribution

  • 00817439020840 ()
HCGCTLB

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control

MedTest DX HCG Control Set Level A - 00817439020833

HCG Control Set Level A, for In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is intended for determining “Hook-Dose Effect” and the accuracy and precision of dilution protocols. Size: 4 x 2.5 ml
Medtest Dx, Inc.
HCG-CTLA
In Commercial Distribution

  • 00817439020833 ()
HCG-CTLA

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control

MedTest DX Elevated HCG Control Vial Label - A - 00817439020826

Elevated HCG Control Vial Label - A, for In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is intended for determining “Hook-Dose Effect” and the accuracy and precision of dilution protocols. Size: 1 x 2.5 mL.
Medtest Dx, Inc.
HCGCTLA
In Commercial Distribution

  • 00817439020826 ()
HCGCTLA

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control

MedTest DX HCG Control Set - 00817439020819

HCG Control Set, for In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is intended for determining “Hook-Dose Effect” and the accuracy and precision of dilution protocols. Size: 4 x 2.5 mL.
Medtest Dx, Inc.
HCG-CTL
In Commercial Distribution

  • 00817439020819 ()
HCG-CTL

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control
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