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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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The illumigene HSV 1&2 External Control Kit contains Positive and Negative Control Reagents for use with the illumigene HSV 1&2 DNA Amplification Assay. External controls are used as part of a routine quality control program.
MERIDIAN BIOSCIENCE, INC.
279960
Not in Commercial Distribution

  • 00840733101151 ()
279960

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
Set HSV 1 And 2 Control
BECTON, DICKINSON AND COMPANY
441748
Not in Commercial Distribution

  • 00382904417482 ()
441748

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV-1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV-2 infection.
Elitechgroup Mdx LLC
RTK403ING
In Commercial Distribution

  • 03661540951947 ()
RTK403ING

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
Aptima® HSV 1 & 2 Assay Controls Kit.
Hologic, Inc.
KIT, CONTROLS, AHSV, 100T, IVD
In Commercial Distribution

  • 15420045507234 ()
PRD-03569

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
Light Diagnostics HSV 1 & 2 Control Slide
EMD Millipore Corporation
5093
Not in Commercial Distribution

  • 04061841047469 ()
5093

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay
No Description
REMEL EUROPE LIMITED
R62251
In Commercial Distribution

  • 05056080500010 ()


  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay
No Description
REMEL EUROPE LIMITED
R62250
In Commercial Distribution

  • 05056080500003 ()


  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay
MicroTrak® HSV 1 /HSV 2 Direct Specimen - Collection Kit
TRINITY BIOTECH PUBLIC LIMITED COMPANY
8H329UL
Not in Commercial Distribution

  • 05391516748643 ()
  • 05391516746137 ()

  • 1 Kit
8H329UL

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay
MicroTrak® HSV-1/HSV-2 Direct Specimen Identification/Typing Test
TRINITY BIOTECH PUBLIC LIMITED COMPANY
8H349UL
Not in Commercial Distribution

  • 05391516746038 ()

  • 60 Tests
8H349UL

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay
MicroTrak® HSV-1/HSV-2 Culture Identification/Typing Test
TRINITY BIOTECH PUBLIC LIMITED COMPANY
8H219UL
Not in Commercial Distribution

  • 05391516746007 ()

  • 18-85 Tests
8H219UL

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay
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