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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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No Description
DIASORIN MOLECULAR LLC
EL0904
In Commercial Distribution

  • 10816101022080 ()
EL0904

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG)/IgM antibody IVD, control
No Description
DIASORIN MOLECULAR LLC
IB0910
In Commercial Distribution

  • 10816101021038 ()
IB0910

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, immunoblot
No Description
DIASORIN MOLECULAR LLC
IB0913
In Commercial Distribution

  • 10816101021021 ()
IB0913

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, immunoblot
No Description
DIASORIN MOLECULAR LLC
MOL2150
In Commercial Distribution

  • 20816101025507 ()
MOL2150

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Diagnostics GmbH
08948887160
In Commercial Distribution

  • 07613336170694 ()
08948887160

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08948909190
In Commercial Distribution

  • 07613336170687 ()
08948909190

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08948844160
In Commercial Distribution

  • 07613336170663 ()
08948844160

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08948852190
In Commercial Distribution

  • 07613336170656 ()
08948852190

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
The Alethia™ HSV 1&2 DNA amplification assay, performed on the Alethia™ Instrument, is a qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. Alethia™ HSV 1&2 utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect HSV-1 and HSV-2 by targeting segments of the herpes simplex virus 1 and herpes simplex virus 2 genomes. Results from Alethia™ HSV 1&2 are used as an aid in the diagnosis of HSV infection in symptomatic patients.
MERIDIAN BIOSCIENCE, INC.
480650
In Commercial Distribution

  • 00840733102219 ()
480650

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, kit, nucleic acid technique (NAT)
The illumigene HSV 1&2 DNA amplification assay, performed on the illumipro-10, is a qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. illumigene HSV 1&2 utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect HSV-1 and HSV-2 by targeting segments of the herpes simplex virus 1 and herpes simplex virus 2 genomes. Results from illumigene HSV 1&2 are used as an aid in the diagnosis of HSV infection in symptomatic patients.
MERIDIAN BIOSCIENCE, INC.
280650
Not in Commercial Distribution

  • 00840733101182 ()
280650

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, kit, nucleic acid technique (NAT)
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