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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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RADI EXTRACTOR 32 is an instrument capable of extracting nucleic acid needed in various sample as blood, serum, sputum and tissues for the gene amplification test. RADI EXTRACTOR 32 instrument is designed for use by laboratory professionals. RADI EXTRACTOR 32 has various functions such as liquid handling, bead mixing, sample lysis, nucleic acid separation, etc. Also, with its compact size and light weight, it offers high efficiency in terms of space and portability. It is convenient for users to easily use the instrument through a user interface in the LCD touch screen. The protocol which is used for by USB port, and all the functions including modification of Extraction protocol from the control software in the PC can be used. All the protocols the user edited are stored in System.
KH Medical Co., Ltd.
OE005
In Commercial Distribution

  • 08800204300133 ()


  • Nucleic acid sample preparation instrument IVD
RADI EXTRACTOR 192 is an instrument capable of extracting nucleic acid needed in various sample as blood, serum, sputum and tissues for the gene amplification test. RADI EXTRACTOR 192 instrument is designed for use by laboratory professionals. RADI EXTRACTOR 192 has various functions such as liquid handling, bead mixing, sample lysis, nucleic acid separation, etc. Also, with its compact size and light weight, it offers high efficiency in terms of space and portability. It is convenient for users to easily use the instrument through a user interface in the LCD touch screen. The protocol which is used for by USB port, and all the functions including modification of Extraction protocol from the control software in the PC can be used. All the protocols the user edited are stored in System.
KH Medical Co., Ltd.
OE006
In Commercial Distribution

  • 08800204300027 ()


  • Nucleic acid sample preparation instrument IVD
"720-650 EBV-EA-D IgM Test Kit"
DIAMEDIX CORPORATION
720-650
In Commercial Distribution

  • 00817273020365 ()


  • Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, kit, immunoblot
"720-620 EBNA-1 IgG Test Kit"
DIAMEDIX CORPORATION
720-620
In Commercial Distribution

  • 00817273020334 ()


  • Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, kit, immunoblot
"720-600 EBV-VCA IgG Test Kit"
DIAMEDIX CORPORATION
720-600
In Commercial Distribution

  • 00817273020310 ()


  • Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, kit, immunoblot
Rapid Urea Medium, useful for Helicobacter pylori, 2ml, 15x45mm tube, 10 per box Rapid Urea Medium for rapid detection of urease activity in Helicobacter pylori, Cryptococcus neoformans, or Proteus spp. Biopsy specimen from endoscopy can be submerged into the agar, positive reactions (pink-red color) may be noted within minutes.
HARDY DIAGNOSTICS
Z54
In Commercial Distribution

  • 00819398026550 ()
  • 00819398026567 ()
Z54

  • Differential/selective broth culture medium IVD
Caffeic Acid Agar Slant (Bird Seed Agar), for Cryptococcus, 16x100mm tube, order by the package of 20 For the selective isolation and differentiation of Cryptococcus neoformans and Cryptococcus gattii. Also known as Bird Seed Agar or Niger Seed Agar.
HARDY DIAGNOSTICS
L13
Not in Commercial Distribution

  • 00819398022002 ()
  • 00819398022019 ()
L13

  • Differential/selective agar culture medium IVD
Caffeic Acid Disks, for Cryptococcus, 25 disks per pack HardyDisk™ Caffeic Acid Disks detect the ability of an organism to produce the enzyme phenyloxidase, which is useful for the identification of Cryptococcus neoformans and Cryptococcus gattii.
HARDY DIAGNOSTICS
Z118
In Commercial Distribution

  • 00819398027557 ()
  • 00819398028578 ()
Z118

  • Multiple-type meningitis pathogen nucleic acid IVD, reagent
Microbiology Slides Blood Parasite Control Slide
MICROBIOLOGICS INC.
SL90-05
Not in Commercial Distribution

  • 10845357043471 ()
SL90-05

  • Multiple faecal parasite antigen IVD, control
Helix Elite™ Molecular Standards Inactivated Cryptosporidium and Giardia
MICROBIOLOGICS INC.
HE0049N
Not in Commercial Distribution

  • 10845357042207 ()
HE0049N

  • Multiple faecal parasite antigen IVD, control
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