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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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Stat Profile - 00385480616058

Stat Profile Prime Plus MicroSensor Card™ with COOX 100
NOVA BIOMEDICAL CORPORATION
Prime Plus
In Commercial Distribution

  • 10385480616055 ()
  • 00385480616058 ()
61605

  • Single-channel clinical chemistry analyser IVD, point-of-care

Stat Profile - 00385480614542

Prime Sensor Card ES Comp Plus
NOVA BIOMEDICAL CORPORATION
Prime ES Comp Plus
In Commercial Distribution

  • 10385480614549 ()
  • 00385480614542 ()
61454

  • Multichannel clinical chemistry analyser IVD, point-of-care, line-powered

Stat Profile - 00385480614535

Prime Sensor Card ES Plus
NOVA BIOMEDICAL CORPORATION
Prime ES Plus
In Commercial Distribution

  • 10385480614532 ()
  • 00385480614535 ()
61453

  • Multichannel clinical chemistry analyser IVD, point-of-care, line-powered

Eco-S - 08809254454308

Resin-base Pit and Fissure sealant ; Eco-S 0.5g x 1 syringe
VERICOM CO., LTD.
ES105-S000
In Commercial Distribution

  • 08809254454308 ()


  • Dental unfilled resin sealant

Eco-S - 08809254451826

Resin-base Pit and Fissure sealant ; Eco-S 1.2ml x 1 syringe
VERICOM CO., LTD.
ES105-R000
In Commercial Distribution

  • 08809254451826 ()


  • Dental unfilled resin sealant

Eco-S - 08809254451819

Resin-base Pit and Fissure sealant ; Eco-S 1.2ml x 4 syringes
VERICOM CO., LTD.
ES105-RK00
In Commercial Distribution

  • 08809254451819 ()


  • Dental unfilled resin sealant

Urine Calibration Standard - 04250317543738

Urine Calibration Standard Crosslinks
Chromsystems Instruments + Chemicals GmbH
48003
In Commercial Distribution

  • 04250317510006 ()
  • 04250317543738 ()

  • 5 x 1ml
48003

  • Pyridinoline (PYD) IVD, calibrator

Urine Control - 04250317543721

Urine Control Level II Crosslinks in urine
Chromsystems Instruments + Chemicals GmbH
0047
In Commercial Distribution

  • 04250317509383 ()
  • 04250317543721 ()

  • 5 x 2ml
0047

  • Pyridinoline (PYD) IVD, control

Urine Control - 04250317543707

Urine Control Level I, Crosslinks in urine
Chromsystems Instruments + Chemicals GmbH
0046
In Commercial Distribution

  • 04250317509093 ()
  • 04250317543707 ()

  • 5 x 2ml
0046

  • Pyridinoline (PYD) IVD, control

HEMOSURE® - 00857338006347

Hemosure hCG Controls Set 2ml.
HEMOSURE INC.
F2-TC01
In Commercial Distribution

  • 00857338006347 ()
F2-TC01

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control
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