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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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cobas® 4800 System Sample Preparation Kit - 00875197003178

No Description
Roche Molecular Systems, Inc.
05235782190
In Commercial Distribution

  • 00875197003178 ()
05235782190

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

Aptima® - 15420045500082

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® - 15420045500075

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® - 15420045500068

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® - 15420045500051

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)

HPV-HR - 15420045504271

No Description
Hologic, Inc.
GENFIND DNA EXTRACTION KIT
Not in Commercial Distribution

  • 15420045504271 ()
95-449

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

Cervista HTA System - 15420045501065

No Description
Hologic, Inc.
Cervista HTA System Computer
Not in Commercial Distribution

  • 15420045501065 ()


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

Cervista Manual System - 15420045501058

No Description
Hologic, Inc.
Cervista Manual System Computer
Not in Commercial Distribution

  • 15420045501058 ()


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

Cervista HTA System - 15420045500969

No Description
Hologic, Inc.
Cervista HTA System
Not in Commercial Distribution

  • 15420045500969 ()


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

Cervista HTA System - 15420045500952

No Description
Hologic, Inc.
Cervista HTA System
Not in Commercial Distribution

  • 15420045500952 ()


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