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

  • 00812242030048 ()
CMVL101

  • Cytomegalovirus (CMV) nucleic acid IVD, control
CMV Verification Panel
EXACT DIAGNOSTICS, LLC
CMVP100
In Commercial Distribution

  • 00812242030031 ()
CMVP100

  • Cytomegalovirus (CMV) nucleic acid IVD, calibrator
HIV-1 High Run Control
EXACT DIAGNOSTICS, LLC
HIVH102
In Commercial Distribution

  • 00812242030024 ()
HIVH102

  • HIV1 nucleic acid IVD, control
HIV-1 Low Run Control
EXACT DIAGNOSTICS, LLC
HIVL101
In Commercial Distribution

  • 00812242030017 ()
HIVL101

  • HIV1 nucleic acid IVD, control
HIV-1 Verification Panel
EXACT DIAGNOSTICS, LLC
HIVP100
In Commercial Distribution

  • 00812242030000 ()
HIVP100

  • HIV1 nucleic acid IVD, calibrator
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
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
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
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
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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