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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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Determine™ HIV–1/2 Ag/Ab Combo is an in vitro, visually read, qualitative immunoassay for the simultaneous detection of HIV-1 p24 antigen (Ag) and antibodies (Ab) to HIV-1 and HIV-2 in human serum, plasma, capillary (fingerstick) whole blood or venipuncture (venous) whole blood.
Alere Scarborough, Inc.
7D2648
In Commercial Distribution

  • 00811877011101 ()


  • HIV1/HIV2 antigen/antibody IVD, kit, rapid ICT, clinical
No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 07290110123055 ()
AAVF16042301

  • Liposuction system
No Description
ESTAR TECHNOLOGIES LTD
06212SC
Not in Commercial Distribution

  • 17290015874202 ()
06212SC

  • Haematological concentrate system preparation kit, platelet concentration
HemoCue Hb 301 Microcuvettes 4x75 vial
Hemocue AB
111814
In Commercial Distribution

  • 27311091118077 ()
  • 17311091118148 ()
111814

  • Haemoglobin analyser IVD, point-of-care
HemoCue Hb 301 Microcuvettes 4x50 vial
Hemocue AB
111801
In Commercial Distribution

  • 07311091118011 ()
  • 17311091118018 ()
  • 27311091118015 ()
111801

  • Haemoglobin analyser IVD, point-of-care
HemoCue Plasma/Low Hb Microcuvettes 4x25 vial
Hemocue AB
110302
In Commercial Distribution

  • 07311091103024 ()
  • 17311091103021 ()
  • 27311091103028 ()
110302

  • Haemoglobin analyser IVD, point-of-care
SEG is intended to aid extraction of a biological fluid sample from a segmented piece of tubing.
ITL ASIA PACIFIC SDN. BHD.
A200200
Not in Commercial Distribution

  • 19555240401349 ()
  • 19555240401332 ()
  • 19555240401356 ()
A200200

  • Blood donor bag segment sampling IVD
DonorCare® Needle Guard is intended to aid in the prevention of accidental needle stick injuries upon completion of blood collection procedures.
ITL ASIA PACIFIC SDN. BHD.
A100150
In Commercial Distribution

  • 09555240400154 ()
  • 19555240400151 ()
A100150

  • Needle guard
DonorCare Needle Guard is intended to aid in the prevention of accidental needle stick injuries upon completion of blood collection procedures.
ITL ASIA PACIFIC SDN. BHD.
A100100
In Commercial Distribution

  • 09555240400130 ()
  • 19555240400137 ()
A100100

  • Needle guard
No Description
Microgenics Corporation
963601
In Commercial Distribution

  • 00884883005921 ()


  • Hepatitis C virus antibody/antigen IVD, control
No Description
Microgenics Corporation
960600
Not in Commercial Distribution

  • 00884883005907 ()


  • West Nile virus nucleic acid IVD, control
No Description
Microgenics Corporation
963600
In Commercial Distribution

  • 00884883005945 ()


  • PCR/NAT negative control IVD
No Description
Microgenics Corporation
963602
In Commercial Distribution

  • 00884883005891 ()


  • HIV1 nucleic acid IVD, control
3-NCC987 SCD Wafer
TERUMO BCT, INC.
3NCC987
In Commercial Distribution

  • 55020583260318 ()
  • 35020583260314 ()
  • 05020583260313 ()


  • Package sealing unit
No Description
SCC SOFT COMPUTER
1.0.0.18
In Commercial Distribution

  • 00810055812257 ()


  • Bedside information system application software
No Description
SCC SOFT COMPUTER
25.5.6.2
In Commercial Distribution

  • 00810055810727 ()


  • Blood bank information system application software
HemoCue Plasma/Low Hb Photometer mg/dL
Hemocue AB
120314
In Commercial Distribution

  • 07311091203144 ()
120314

  • Haemoglobin analyser IVD, point-of-care
3M™ Ranger™ Hose Cap, 12 per Case, 90026
3M COMPANY
90026
In Commercial Distribution

  • 50707387781922 ()
  • 00707387781927 ()
90026

  • Conduction blood/fluid warmer set
Syphilis PC Elecsys
Roche Diagnostics GmbH
06923364162
In Commercial Distribution

  • 07613336183175 ()
06923364162

  • Treponema pallidum total antibody IVD, control
No Description
Roche Diagnostics GmbH
04784600162
In Commercial Distribution

  • 07613336183151 ()
04784600162

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control
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