Address:12F, 5, Digital-ro 26-gil,Seoul,KR
Device Description : FREND™ TSH Linearity Kit is intended for use as an assayed linearity material fo FREND™ TSH Linearity Kit is intended for use as an assayed linearity material for the thyroid stimulating hormone (TSH) on the FREND™ System. The Linearity Kit is for the FREND™ System only.FREND™ TSH Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution.
Device Class : 1
Duns Number: 687910463
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The C-Chip is a disposable plastic chamber used for blood cell (Erythrocyte, Leu The C-Chip is a disposable plastic chamber used for blood cell (Erythrocyte, Leukocyte) counting. It consists of surface-patterned two enclosed chambers with two ports for sample injection. The DHC-B01 grid pattern is exactly the same as the Burker. It consists of 9 large squares, each measuring 1 x 1 mm, and the depth of the chamber is 0.1 mm. Each square has a total volume of 0.1 mm3 or 10-4 cm3.The large squares are subdivided into 16 group squares with 0.2 mm sides. The group squares correspond in size to the Neubauer grid but have no further subdivisions.
Device Class : 1
Duns Number: 687910463
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The C-Chip is a disposable plastic chamber used for blood cell (Erythrocyte, Leu The C-Chip is a disposable plastic chamber used for blood cell (Erythrocyte, Leukocyte) counting. It consists of surface-patterned two enclosed chambers with two ports for sample injection. The DHC-B02 grid pattern is exactly the same as the Burker-Turk. It consists of 9 large squares, each measuring 1 x 1 mm and the depth of the chamber is 0.1 mm. Each square has a total volume of 0.1 mm3 or 10-4 cm3.The large squares are subdivided into 16 group squares with 0.2 mm sides. In the central large square, each group is subdivided into 16 mini squares with 0.05 mm sides (=0.0025 mm2).
Device Class : 1
Duns Number: 687910463
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The C-Chip is a disposable plastic chamber used for blood cell (Erythrocyte, Leu The C-Chip is a disposable plastic chamber used for blood cell (Erythrocyte, Leukocyte) counting. It consists of surface-patterned two enclosed chambers with two ports for sample injection. The DHC-F01 grid pattern is exactly the same as the Fuchs-Rosenthal. It consists of 16 large squares orientated by triple lines, each measuring 1 x 1 mm, giving a total area 4 x 4 mm.
Device Class : 1
Duns Number: 687910463
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The C-Chip is a disposable plastic chamber used for blood cell (Erythrocyte, Leu The C-Chip is a disposable plastic chamber used for blood cell (Erythrocyte, Leukocyte) counting. It consists of surface-patterned two enclosed chambers with two ports for sample injection. The DHC-M01 grid pattern is exactly same as the Malassez. It consists of 25 large squares, each measuring 0.2 x 0.25 mm and the depth of the chamber is 0.2 mm. Each square has a total volume of 0.01 mm3 or 10-5 cm3.The large squares are subdivided into 20 small squares with an area of 0.0025 mm2.Cells per mL = average count per large square x dilution factor x 105 (dilution factor)
Device Class : 1
Duns Number: 687910463
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : ADAMII is a device to count stained CD series (e.g. CD34, CD3, CD4, CD8, CD45, e ADAMII is a device to count stained CD series (e.g. CD34, CD3, CD4, CD8, CD45, etc.) in human sample as an aid in the management of patients.
Device Class : 2
Duns Number: 687910463
Premarket Exempt : No
Prescription Use : Yes
Device Description : ADAMII-CD34 Kit is designed for use with the ADAMII instrument, benchtop image-b ADAMII-CD34 Kit is designed for use with the ADAMII instrument, benchtop image-based fluorescence cell counter.ADAMII-CD34 Kit provides the percentages of total and viable cells that are CD34+(%CD34).
Device Class : 2
Duns Number: 687910463
Premarket Exempt : No
Prescription Use : Yes
Device Description : The DHC-N04 grid pattern is exactly same as the Neubauer Improved. It consists o The DHC-N04 grid pattern is exactly same as the Neubauer Improved. It consists of 9 large squares, each measuring 1 x 1 mm, and the depth of the chamber is 0.1 mm. Each square has a total volume of 0.1 mm3 or 10-4 cm3.
Device Class : 1
Duns Number: 687910463
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The DHC-N0420 grid pattern is exactly same as the Neubauer Improved. It consists The DHC-N0420 grid pattern is exactly same as the Neubauer Improved. It consists of 9 large squares, each measuring 1 x 1 mm, and the depth of the chamber is 0.1 mm. Each square has a total volume of 0.1 mm3 or 10-4 cm3.
Device Class : 1
Duns Number: 687910463
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The DHC-B04 grid pattern is exactly same as the Burker. It consists of 9 large s The DHC-B04 grid pattern is exactly same as the Burker. It consists of 9 large squares, each measuring 1 x 1 mm, and the depth of the chamber is 0.1 mm. Each square has a total volume of 0.1 mm3 or 10-4 cm3.
Device Class : 1
Duns Number: 687910463
Premarket Exempt : Yes
Prescription Use : Yes