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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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The Para-Tect Cryptosporidium/Giardia kit is intended to detect Cryptosporidium oocysts and Giardia cysts in human stool by direct immunofluorescence microscopy. This kit contains enough reagents for 75 tests.
MEDICAL CHEMICAL CORPORATION
MCC-C/G-DFA 75
In Commercial Distribution

  • M445MCCCGDFA750 ()
MCC-C/G-DFA 75

  • Multiple faecal parasite antigen IVD, kit, direct fluorescent test (DFT)
The Chembio HIV 1/2 STAT-PAK® Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, serum or plasma specimens. The Chembio HIV 1/2 STAT-PAK® assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 20 individually pouched tests, 1 bottle of HIV Running Buffer, 20 Disposable Loops, 1 Product Insert, and 20 Copies of Subject Information Notice.
Chembio Diagnostic Systems Inc.
60-9505-1
In Commercial Distribution

  • 00607158000052 ()


  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
The Liofilchem® MTS™ (MIC Test Strip) is a quantitative method intended for the in vitro determination ofantimicrobial susceptibility of bacteria MTS™ consists ofspecialized papyr impregnated with a pre-defined concentration gradient ofan antimicrobial agent, which is used to determine the minimum inhibitozy concentration (MIC) in µglmL ofantimicrobial agents against bacteria as tested on agar media using ovemight incubation and manual reading procedures. The MTS™ Plazomicin at concentrations of0.016-256 µglmL should be interpreted at 16-20 hours of incubation. MTS™ PLZ can be used to dete1mine the MIC ofplazomicin against the microorganisms listed below: Plazomicin Activity According to the FDA Label Clinical and in vitro Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Proteus mirabilis in vitro only Citrobacterfreundii Citrobacter koseri Klebsiella (Enterobacter) aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia stuartii Serratia marcescens
LIOFILCHEM SRL
Plazomicin 0.016-256 µg/mL
In Commercial Distribution

  • 08055182872367 ()
  • 08055182872343 ()
  • 18055182872364 ()
$92070-10

  • Plazomicin minimum inhibitory concentration (MIC) IVD
The Liofilchem® MTS™ (MIC Test Strip) is a quantitative method intended for the in vitro determination ofantimicrobial susceptibility of bacteria MTS™ consists ofspecialized papyr impregnated with a pre-defined concentration gradient ofan antimicrobial agent, which is used to determine the minimum inhibitozy concentration (MIC) in µglmL ofantimicrobial agents against bacteria as tested on agar media using ovemight incubation and manual reading procedures. The MTS™ Plazomicin at concentrations of0.016-256 µglmL should be interpreted at 16-20 hours of incubation. MTS™ PLZ can be used to dete1mine the MIC ofplazomicin against the microorganisms listed below: Plazomicin Activity According to the FDA Label Clinical and in vitro Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Proteus mirabilis in vitro only Citrobacterfreundii Citrobacter koseri Klebsiella (Enterobacter) aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia stuartii Serratia marcescens
LIOFILCHEM SRL
Plazomicin 0.016-256 µg/mL
In Commercial Distribution

  • 28055182872354 ()
  • 08055182872350 ()
  • 18055182872357 ()
$92070-1

  • Plazomicin minimum inhibitory concentration (MIC) IVD
• 3 Ply - Disposable High Filtration Face Mask • Face Mask Size: 170mm x 90mm (± 5 mm) • Non - sterile, single use • Color Yellow • 50 masks pack in one box • Box dimensions: 185x105x90mm
PHU BAO GROUP COMPANY LIMITED
Yellow
In Commercial Distribution

  • 89385048060900 ()
  • 08938504806090 ()


  • Surgical/medical face mask, single-use
• 3 Ply - Disposable High Filtration Face Mask • Face Mask Size: 170mm x 90mm (± 5 mm) • Non - sterile, single use • Color Pink • 50 masks pack in one box • Box dimensions: 185x105x90mm
PHU BAO GROUP COMPANY LIMITED
Pink
In Commercial Distribution

  • 89385048060832 ()
  • 08938504806083 ()


  • Surgical/medical face mask, single-use
• 3 Ply - Disposable High Filtration Face Mask • Face Mask Size: 170mm x 90mm (± 5 mm) • Non - sterile, single use • Color Green • 50 masks pack in one box • Box dimensions: 185x105x90mm
PHU BAO GROUP COMPANY LIMITED
Green
In Commercial Distribution

  • 89385048060764 ()
  • 08938504806076 ()


  • Surgical/medical face mask, single-use
• 3 Ply - Disposable High Filtration Face Mask • Face Mask Size: 170mm x 90mm (± 5 mm) • Non - sterile, single use • Color Blue • 50 masks pack in one box • Box dimensions: 185x105x90mm
PHU BAO GROUP COMPANY LIMITED
Blue
In Commercial Distribution

  • 89385048060696 ()
  • 08938504806069 ()


  • Surgical/medical face mask, single-use
• 3 Ply - Disposable High Filtration Face Mask • Face Mask Size: 170mm x 90mm (± 5 mm) • Non - sterile, single use • Color White • 50 masks pack in one box • Box dimensions: 185x105x90mm
PHU BAO GROUP COMPANY LIMITED
White
In Commercial Distribution

  • 89385048060450 ()
  • 08938504806045 ()


  • Surgical/medical face mask, single-use
Soft-Release-ST is an infusion set to connect to SOOIL's insulin reservoir for using insulin pump. It is inserted in the subcutaneous tissue and Not intended for use into blood vessel.
SOOIL DEVELOPMENT CO.,LTD
SR112
In Commercial Distribution

  • 08809220580413 ()
  • 08809220580758 ()
  • 08809220580949 ()

  • Weight: 10.7 Gram
  • Outer Diameter: 1.5 Millimeter
  • Needle Gauge: 24 Gauge
  • Length: 700 Millimeter


  • Ambulatory insulin infusion pump, electronic
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