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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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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)
2 Port Manifold Kit
ARGON MEDICAL DEVICES, INC.
194351A
In Commercial Distribution

  • 20886333207781 ()
  • 00886333207787 ()
194351A

  • Angiography kit
ArgoTrans Model 2 / Neonatal 14" Cable
ARGON MEDICAL DEVICES, INC.
041588505A
Not in Commercial Distribution

  • 20886333201772 ()
  • 00886333201778 ()

  • 14" Cable
041588505A

  • Invasive blood pressure transducer set
ArgoTrans Model 2 / Macro 9" Ext, 6' Line, Stopcock
ARGON MEDICAL DEVICES, INC.
041585505A
Not in Commercial Distribution

  • 20886333201741 ()
  • 00886333201747 ()
041585505A

  • Invasive blood pressure transducer set
ArgoTrans Model 2/Macro 9" Line, Stopcock
ARGON MEDICAL DEVICES, INC.
041582505A
Not in Commercial Distribution

  • 20886333201703 ()
  • 00886333201709 ()

  • 9" Line
041582505A

  • Invasive blood pressure transducer set
6F Introducer Mini Kit/2
ARGON MEDICAL DEVICES, INC.
496226
Not in Commercial Distribution

  • 20886333213928 ()
  • 00886333213924 ()

  • 6F
496226

  • Vascular catheter introduction set, nonimplantable
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