KH Medical Co., Ltd.

Address:201, Jinwiseo-ro, Jinwi-myeon,Pyeongtaek-si Gyeonggi,KR

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Device Description : RADI PREP PLUS(Refer to Figure 1.) is an instrument capable of extracting nuclei RADI PREP PLUS(Refer to Figure 1.) is an instrument capable of extracting nucleic acid needed in various sample as blood, serum, sputum and tissues for the gene amplification test. RADI PREP PLUS instrument is designed for use by laboratory professionals. 8 samples can be prepared in a single run. This Instrument is controlled through a graphical user interface.RADI PREP PLUS 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 7 inches 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.

Device Class : 1

Duns Number: 695801965

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

Device Description : RADI EXTRACTOR 192 is an instrument capable of extracting nucleic acid needed in 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.

Device Class : 1

Duns Number: 695801965

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

Device Description : This product is a nucleic acid extraction reagent capable of extracting high-pur This product is a nucleic acid extraction reagent capable of extracting high-purity DNA/RNA from plasma, saliva, feces, urine, amniotic fluid, and bone marrow of suspected virus infection patients using a Buffer Cartridge dispensed with reagents necessary for nucleic acid extraction.

Device Class :

Duns Number: 695801965

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Device Description : The RADI CHAMP260 is a stand-alone automated isothermal amplification and detec The RADI CHAMP260 is a stand-alone automated isothermal amplification and detection system for target nucleic acid sequences found in human specimens. The instrument is used in conjunction with KH Medical’s LOOP-Mediated Amplification in vitro diagnostic products.RADI CHAMP260 is designed to freely manipulate specific temperature and running time for amplification of samples by 7 inch touch screen.Amplification of target DNA occurs during the heat cycle and results in the formation of precipitate detected by the RADI CHAMP260 optics system. The precipitate generated by the presence of amplified target DNA leads to a turbid Sample/Control reaction solution which is then measured by absorbance. The RADI CHAMP260 uses the change in turbidity of each Sample/Control reaction solution to report assay results as INVALID, POSITIVE, or NEGATIVE on the 7 inch touch screen.

Device Class : 2

Duns Number: 695801965

Premarket Exempt : Yes

Product Code : OOI

Prescription Use : No

Device Count : 1

Device Description : The RADI PREP PLUS 48 is designed as a fully automated instrument for nucleic ac The RADI PREP PLUS 48 is designed as a fully automated instrument for nucleic acid extraction and purification from various biological samples including tissue, cell culture, whole blood, serum, plasma, swab, Bacteria, yeast, etc.

Device Class : 1

Duns Number: 695801965

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

Device Description : RADI EXTRACTOR 32 is an instrument capable of extracting nucleic acid needed in 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.

Device Class : 1

Duns Number: 695801965

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

Device Class : 1

Duns Number: 695801965

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

Device Description : This product is based on magnetic extraction method that separates nucleic acids This product is based on magnetic extraction method that separates nucleic acids using a silica-coated magnetic bead. The sample is first lysed by the provided Lysis buffer to expose the nucleic acid, and the exposed nucleic acid is binds to the Silica-coated magnetic bead, and impurities are removed by the washing buffer. After this, the purified DNA/RNA is eluted with an Elution buffer.

Device Class :

Duns Number: 695801965

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Device Description : The RADI 192 Tissue DNA/RNA Extraction kit is a reagent intended to extract nucl The RADI 192 Tissue DNA/RNA Extraction kit is a reagent intended to extract nucleic acids from fresh or frozen tissues and cultured cells. Automated nucleic acid extraction can be performed by using RADI 192 Extractor only. The extracted nucleic acid can be used in all experiments that require nucleic acids, such as real-time PCR and NGS.The kit is intended to be used by a laboratory professional.

Device Class :

Duns Number: 695801965

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Device Description : The RADI 192 Bacteria DNA/RNA Extraction kit is a reagent intended to extract Ba The RADI 192 Bacteria DNA/RNA Extraction kit is a reagent intended to extract Bacterial DNA and RNA from urine, stool, swab and pre-treated sputum (NaOH, NALC). Automated nucleic acid extraction can be performed with this kit by using RADI 192 Extractor only. The extracted nucleic acid can be used in all experiments that require nucleic acids, such as real-time PCR and NGS.The kit is intended to be use by a laboratory professional.

Device Class :

Duns Number: 695801965

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1