Bioneer Corporation

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) (10)

Premarket Exempt

Yes

Clear

ExiPrep™ Dx Viral RNA Kit - 08809357174134 Catalog Number : K-4473

Device Description : 96 test/kit

Device Class : 1

Duns Number: 688014216

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : Yes

Device Count : 1

ExiPrep™ Dx Viral DNA/RNA Kit - 08809357174158 Catalog Number : K-4471

Device Description : 96 test/kit

Device Class : 1

Duns Number: 688014216

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : Yes

Device Count : 1

ExiPrep™ Dx Viral DNA Kit - 08809357174172 Catalog Number : K-4472

Device Description : 96 test/kit

Device Class : 1

Duns Number: 688014216

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : Yes

Device Count : 1

ExiPrep™ Dx Blood Genomic DNA Kit - 08809357174196 Catalog Number : K-4411

Device Description : 96 test/kit

Device Class : 1

Duns Number: 688014216

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : Yes

Device Count : 1

ExiPrep™ Dx Bacteria Genomic DNA Kit - 08809357174219 Catalog Number : K-4414

Device Description : 96 test/kit

Device Class : 1

Duns Number: 688014216

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : Yes

Device Count : 1

ExiPrep™ Dx Mycobacteria Genomic DNA Kit - 08809357174233 Catalog Number : K-4418

Device Description : 96 test/kit

Device Class : 1

Duns Number: 688014216

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : Yes

Device Count : 1

ExiPrep™ 48 Viral DNA/RNA Kit - 08809357178309 Catalog Number : K-4571

Device Description : 96 test/kit

Device Class : 1

Duns Number: 688014216

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : Yes

Device Count : 1

ExiPrep™ 48 Viral RNA Kit - 08809357178316 Catalog Number : K-4573

Device Description : 96 test/kit

Device Class : 1

Duns Number: 688014216

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : Yes

Device Count : 1

ExiPrep™ 96 Viral DNA/RNA Kit - 08809357179481 Catalog Number : K-4614

Device Description : 384 test/kit

Device Class : 1

Duns Number: 688014216

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : Yes

Device Count : 1

MagListo™ 5M Viral DNA/RNA Extraction Kit - 08809357179498 Catalog Number : K-3617

Device Description : 100 test/kit

Device Class : 1

Duns Number: 688014216

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : Yes

Device Count : 1

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