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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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TCOAG IRELAND LIMITED
T4304
In Commercial Distribution

  • 15391521420784 ()
  • 05391521420787 ()


  • D-dimer IVD, control
Aptima Combo 2® Assay, 100 test, box 1 of 2 (2°C to 8°C box). The Aptima Combo 2® Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal disease using the Panther® System as specified.
Hologic, Inc.
KIT, BX 1 (REFRIG) AC2, 100T, AS, IVD
In Commercial Distribution

  • 15420045505735 ()
302931

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Aptima Combo 2® Assay, 100 test, box 2 of 2 (15°C to 30°C box). The Aptima Combo 2® Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal disease using the Panther® System as specified.
Hologic, Inc.
KIT, BX 2 (RT) AC2, 100T, AS, IVD
In Commercial Distribution

  • 15420045505728 ()
302939

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Aptima Combo 2® Assay, 250 test, box 1 of 2 (2°C to 8°C box). The Aptima Combo 2® Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease using the Tigris® DTS® Automated Analyzer or semi-automated instrumentation as specified.
Hologic, Inc.
KIT APTIMA COMBO 2 TIGRIS-REF (IVD)-CE
In Commercial Distribution

  • 15420045505711 ()
302307

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Aptima Combo 2® Assay, 250 test, box 2 of 2 (15°C to 30°C box). The Aptima Combo 2® Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease using the Tigris® DTS® Automated Analyzer or semi-automated instrumentation as specified.
Hologic, Inc.
KIT, APTIMA COMBO 2, TIGRIS ROOM TEMP (IVD) CE
In Commercial Distribution

  • 15420045505704 ()
302305

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Aptima Combo 2® Assay, 100 test, box 1 of 2 (2°C to 8°C box). The Aptima Combo 2® Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease using the Tigris® DTS® Automated Analyzer or semi-automated instrumentation as specified.
Hologic, Inc.
KIT,APTIMA COMBO 2 (REFRIG) CE
In Commercial Distribution

  • 15420045505360 ()
301073-02

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Aptima Combo 2® Assay, 100 test, box 2 of 2 (15°C to 30°C box). The Aptima Combo 2® Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease using the Tigris® DTS® Automated Analyzer or semi-automated instrumentation as specified.
Hologic, Inc.
KIT,APT. COMBO 2 (ROOM TEMP)CE
In Commercial Distribution

  • 15420045505353 ()
301072-01

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Shigella Antisera Set 2 - A set containing 8 polyvalent and 11 monovalent antisera for serotyping Shigella, dysenteriae, Shigella flexneri, Shigella boydii and Shigella sonnei strains
MAST GROUP LIMITED
M10105
In Commercial Distribution

  • 15060392378035 ()
M10105

  • Multiple Shigella species culture isolate antigen IVD, kit, agglutination
Aptima Combo 2® Assay, 100 test, box 2 of 2 (15°C to 30°C box). The Aptima Combo 2® assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal disease using the Panther® system as specified.
Hologic, Inc.
KIT,APTIMA COMBO 2,100T,RT,CEIVD-UPDATED
In Commercial Distribution

  • 15420045512900 ()
ASY-13954

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Aptima Combo 2® assay, 100 test, box 1 of 2 (2°C to 8°C box). The Aptima Combo 2® assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal disease using the Panther® system as specified.
Hologic, Inc.
KIT,APTIMACOMBO2,100T,REF,CEIVD-UPDATED
In Commercial Distribution

  • 15420045512894 ()
ASY-13955

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
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