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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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Alinity - 00380740146252

Alinity i HIV Ag/Ab Combo Calibrator
Abbott GmbH
08P0702
In Commercial Distribution

  • 00380740146252 ()
08P0702

  • HIV1/HIV2 antigen/antibody IVD, calibrator

Alinity - 00380740136574

Alinity i HIV Ag/Ab Combo Controls
Abbott GmbH
08P0712
In Commercial Distribution

  • 00380740136574 ()
08P0712

  • HIV1/HIV2 antigen/antibody IVD, control

Biotem - 08800036204173

Biotem IR COM OCTA PLUS ABUTMENT 4.8 mm (D) X 2.9 (Octa) X 4.0 mm(Cuff) X 6.0 mm(H)
Biotem Co., ltd
SAITB4846C
In Commercial Distribution

  • 08800036204173 ()


  • Dental implant system

Biotem - 08800036204166

Biotem IR COM OCTA PLUS ABUTMENT 4.8 mm (D) X 2.9 (Octa) X 2.0 mm(Cuff) X 6.0 mm(H)
Biotem Co., ltd
SAITB4826C
In Commercial Distribution

  • 08800036204166 ()


  • Dental implant system

cobas HPV Positive Control Kit - 00875197006896

No Description
Roche Molecular Systems, Inc.
09040552190
In Commercial Distribution

  • 00875197006896 ()
09040552190

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

cobas HPV - 00875197006889

No Description
Roche Molecular Systems, Inc.
09040544190
In Commercial Distribution

  • 00875197006889 ()
09040544190

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

cobas HPV Positive Control - 00875197005769

No Description
Roche Molecular Systems, Inc.
07460171190
In Commercial Distribution

  • 00875197005769 ()
07460171190

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

cobas HPV for use on the cobas 6800/8800 systems - 00875197005752

No Description
Roche Molecular Systems, Inc.
07460155190
In Commercial Distribution

  • 00875197005752 ()
07460155190

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

cobas® 4800 HPV Amplification/Detection Kit - 00875197003260

No Description
Roche Molecular Systems, Inc.
05235898190
In Commercial Distribution

  • 00875197003260 ()
05235898190

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

cobas® 4800 HPV Amplification/Detection Kit - 00875197003253

No Description
Roche Molecular Systems, Inc.
05235880190
In Commercial Distribution

  • 00875197003253 ()
05235880190

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