Bioneer Corporation

Address:8-11, Munpyeongseo-ro,Daedeok-gu Daejeon,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) (2)

Premarket Exempt

Yes

Clear

ExiPrep™ 96 Genomic DNA Kit - 08809357179870 Catalog Number : K-4611

Device Description : 384 test/kit

Device Class : 1

Duns Number: 688014216

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : Yes

Device Count : 1

Exicycler™ 96 - 08809537070034 Catalog Number : A-2060-1

Device Class : 2

Duns Number: 688014216

Premarket Exempt : Yes

Product Code : OOI

Prescription Use : Yes

Device Count : 1

ExiPrep™48 Dx - 08809537070058 Catalog Number :

Device Class : 1

Duns Number: 688014216

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : Yes

Device Count : 1

ExiPrep™16 Dx - 08809537070065 Catalog Number :

Device Class : 1

Duns Number: 688014216

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : Yes

Device Count : 1

ExiPrep™96 Lite - 08809537070188 Catalog Number :

Device Class : 1

Duns Number: 688014216

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : Yes

Device Count : 1

Protonion™ 96 Viral RNA Kit - 08809537070461 Catalog Number : K-4731

Device Description : 384 test/kit

Device Class : 1

Duns Number: 688014216

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : Yes

Device Count : 1

Exicycler™ 384 - 08809537070751 Catalog Number : A-2061

Device Class : 2

Duns Number: 688014216

Premarket Exempt : Yes

Product Code : OOI

Prescription Use : Yes

Device Count : 1

ExiPrep™16 Plus - 08809537077750 Catalog Number :

Device Class : 1

Duns Number: 688014216

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : Yes

Device Count : 1

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