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) (6) Real Time Nucleic Acid Amplification System (OOI) (1)

Premarket Exempt

Yes

Clear

RADI 48 Viral DNA/RNA Extraction kit - 08800204300539 Catalog Number :

Device Class : 1

Duns Number: 695801965

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

RADI PREP PLUS 48 Swab DNA,RNA Extraction Kit - 08800204300546 Catalog Number :

Device Class : 1

Duns Number: 695801965

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

RADI 48 Whole Blood DNA/RNA Extraction Kit - 08800204300553 Catalog Number :

Device Class : 1

Duns Number: 695801965

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

RADI 48 Tissue DNA Extraction Kit - 08800204300560 Catalog Number :

Device Class : 1

Duns Number: 695801965

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

RADI 48 Bacteria DNA Extraction Kit - 08800204300577 Catalog Number :

Device Class : 1

Duns Number: 695801965

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

RADI PREP PLUS Universal DNA/RNA KIT - 08800204300683 Catalog Number :

Device Class : 1

Duns Number: 695801965

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

RADI PCR 96 Plus - 08800204300690 Catalog Number :

Device Class : 2

Duns Number: 695801965

Premarket Exempt : Yes

Product Code : OOI

Prescription Use : No

Device Count : 1

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