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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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Cervista - 15420045500167

No Description
Hologic, Inc.
HPV 16 18
Not in Commercial Distribution

  • 15420045500167 ()
95-439

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

Cervista - 15420045500150

No Description
Hologic, Inc.
HPV HR (768 Reactions)
Not in Commercial Distribution

  • 15420045500150 ()
PRD-00804

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

Cervista - 15420045500143

No Description
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® - 15420045500136

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® - 15420045500129

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® - 15420045500112

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® - 15420045500105

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® - 15420045500099

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)

Alinity m - 00884999048621

Alinity m HR HPV CTRL Kit
ABBOTT MOLECULAR INC.
09N15-085
In Commercial Distribution

  • 00884999048621 ()
09N15-085

  • Human papillomavirus (HPV) high-risk strain nucleic acid IVD, control

Alinity m - 00884999048614

Alinity m HR HPV AMP Kit
ABBOTT MOLECULAR INC.
09N15-095
In Commercial Distribution

  • 00884999048614 ()
09N15-095

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