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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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Hologic, Inc.
HPV HR (96 Reactions)
Not in Commercial Distribution

  • 15420045500143 ()
95-438

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
Aptima® GT HPV 16 18/45 Genotype Assay Calibrators Kit.
Hologic, Inc.
KIT, APTIMA HPV 16 18/45, CALS IVD
In Commercial Distribution

  • 15420045500136 ()
303235

  • Human papillomavirus (HPV) high-risk strain nucleic acid IVD, calibrator
Aptima® HPV 16 18/45 Genotype Assay, 100 test, box 2 of 2 (15°C to 30°C box).
Hologic, Inc.
KIT, APTIMA HPV 16 18/45, 100 RT IVD
In Commercial Distribution

  • 15420045500129 ()
303231

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
Aptima® HPV 16 18/45 Genotype Assay, 100 test, box 1 of 2 (2°C to 8°C box).
Hologic, Inc.
KIT, APTIMA HPV 16 18/45, 100 REF IVD
In Commercial Distribution

  • 15420045500112 ()
303230

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
Aptima® HPV Assay, 100 test, box 2 of 2 (15°C to 30°C box).
Hologic, Inc.
KIT, BX 2 (RT) HPV,100-T,AS, US IVD
In Commercial Distribution

  • 15420045500105 ()
303572

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
Aptima® HPV Assay, 100 test, box 1 of 2 (2°C to 8°C box).
Hologic, Inc.
KIT, BX 1(REF) HPV,100-T, AS, US IVD
In Commercial Distribution

  • 15420045500099 ()
303573

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
Aptima® HPV Assay Controls Kit.
Hologic, Inc.
KIT,HPV,APTIMA, CONTROLS, IVD
In Commercial Distribution

  • 15420045500082 ()
303011

  • Human papillomavirus (HPV) high-risk strain nucleic acid IVD, control
Aptima® HPV Assay Calibrators Kit.
Hologic, Inc.
KIT,HPV,APTIMA, CALIBRATORS, IVD
In Commercial Distribution

  • 15420045500075 ()
303010

  • Human papillomavirus (HPV) high-risk strain nucleic acid IVD, calibrator
Aptima® HPV Assay, 250 test, box 2 of 2 (15°C to 30°C box).
Hologic, Inc.
KIT,HPV,APTIMA,250 TEST,ROOM TEMP, IVD
In Commercial Distribution

  • 15420045500068 ()
302885

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
Aptima® HPV Assay, 250 test, box 1 of 2 (2°C to 8°C box).
Hologic, Inc.
KIT, HPV, APTIMA, 250 TEST, REFRIG, IVD
In Commercial Distribution

  • 15420045500051 ()
302883

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
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