KH Medical Co., Ltd.

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

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Clinical Sample Concentrator (JJH) (5) Real Time Nucleic Acid Amplification System (OOI) (1)

Premarket Exempt

Yes

Clear

RADI PREP Plus - 08800204300010 Catalog Number :

Device Description : RADI PREP PLUS(Refer to Figure 1.) is an instrument capable of extracting nuclei

Device Class : 1

Duns Number: 695801965

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

RADI Extractor 192 - 08800204300027 Catalog Number :

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

Device Class : 1

Duns Number: 695801965

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

RADI 192 Viral DNA/RNA Extraction Kit - 08800204300034 Catalog Number :

Device Description : This product is a nucleic acid extraction reagent capable of extracting high-pur

Device Class :

Duns Number: 695801965

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

RADI CHAMP260 - 08800204300096 Catalog Number :

Device Description : The RADI CHAMP260 is a stand-alone automated isothermal amplification and detec

Device Class : 2

Duns Number: 695801965

Premarket Exempt : Yes

Product Code : OOI

Prescription Use : No

Device Count : 1

RADI PREP Plus 48 - 08800204300102 Catalog Number :

Device Description : The RADI PREP PLUS 48 is designed as a fully automated instrument for nucleic ac

Device Class : 1

Duns Number: 695801965

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

RADI Extractor 32 - 08800204300133 Catalog Number :

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

Device Class : 1

Duns Number: 695801965

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

RADI PREP PLUS Swab and Stool DNARNA KIT - 08800204300300 Catalog Number :

Device Class : 1

Duns Number: 695801965

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

RADI 192 Viral DNA/RNA Extraction Kit - 08800204300508 Catalog Number :

Device Description : This product is based on magnetic extraction method that separates nucleic acids

Device Class :

Duns Number: 695801965

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

RADI 192 Tissue DNA/RNA Extraction Kit - 08800204300515 Catalog Number :

Device Description : The RADI 192 Tissue DNA/RNA Extraction kit is a reagent intended to extract nucl

Device Class :

Duns Number: 695801965

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

RADI 192 Bacteria DNA/RNA Extraction Kit - 08800204300522 Catalog Number :

Device Description : The RADI 192 Bacteria DNA/RNA Extraction kit is a reagent intended to extract Ba

Device Class :

Duns Number: 695801965

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

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