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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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ABBOTT PRISM HTLV-I/HTLV-II Assay Kit
ABBOTT LABORATORIES
6E50-68
Not in Commercial Distribution

  • 00380740063016 ()
06E5068

  • Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, chemiluminescent immunoassay
Herpes-2 IgG (HSV2) ADVIA Centaur - RGT – 100T
Siemens Healthcare Diagnostics Inc.
10720849
In Commercial Distribution

  • 00630414016726 ()
10720849

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
09015272162
In Commercial Distribution

  • 07613336228470 ()
  • 07613336183090 ()
09015272162

  • Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, chemiluminescent immunoassay
No Description
SCIMEDX CORPORATION
I-HV201X
In Commercial Distribution

  • 00813545025731 ()
I-HV201X

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
SCIMEDX CORPORATION
I-HV201G
In Commercial Distribution

  • 00813545025717 ()
I-HV201G

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
Bion Enterprises, Ltd.
HS2G-120
In Commercial Distribution

  • B110HS2G1200 ()
HS2G-120

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
MGB Alert HSV-2 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotides designed to detect nucleic acid sequences within the glycoprotein-G gene of HSV-2. The mix consists of a total of 1.44 nmol of probe per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm.
Elitechgroup Mdx LLC
M800588
In Commercial Distribution

  • 03661540952036 ()
M800588

  • Herpes simplex virus 2 (HSV2) nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert HSV-2 Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the glycoprotein-G gene of HSV-2. The mix consists of a total of 9.0 nmol of primers per vial in a 1X TE buffer solution. The primers target a 79 bp region of the glycoprotein-G gene of HSV-2.
Elitechgroup Mdx LLC
M800587
In Commercial Distribution

  • 03661540952029 ()
M800587

  • Herpes simplex virus 2 (HSV2) nucleic acid IVD, kit, nucleic acid technique (NAT)
Alinity s HTLV I/II Reagent Kit
Abbott GmbH
06P0760
In Commercial Distribution

  • 00380740117214 ()
06P0760

  • Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, chemiluminescent immunoassay
Herpes-2 IgG (HSV2) Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10733033
In Commercial Distribution

  • 00842768022807 ()
10733033

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
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