3D Biomedicine Science & Technology Co., Limited

Address:Block A, Building 2, No.158 Xinjunhuan Rd.,Shanghai,CN

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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) (4)

Premarket Exempt

Yes

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ReadiMag Pathogen Nucleic Acid Isolation Kit - 06973685471912 Catalog Number : 3000000000359

Device Description : The ReadiMag Pathogen Nucleic Acid Isolation Kit is a system that uses magnetic The ReadiMag Pathogen Nucleic Acid Isolation Kit is a system that uses magnetic beads technology for isolation and purification of Pathogen nucleic acid from biological specimens. The purified nucleic acids can be directly used for the downstream tests. The product is intended to be used by professional users, such as technicians and physicians who are trained in molecular biological techniques.

Device Class : 1

Duns Number: 561011079

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : Yes

Device Count : 1

Automated Nucleic Acids Extraction System ANDiS 350 - 06973685478003 Catalog Number : 3000000000115

Device Description : A mains electricity (AC-powered) laboratory instrument intended to be used for t A mains electricity (AC-powered) laboratory instrument intended to be used for the automated pre-analytical preparation of samples for downstream nucleic acid analysis. The instrument may be used to prepare various sample types through one or more pre-analytical steps which may include cell disruption, lysis, nucleic acid extraction, enzymatic digestion and/or nucleic acid purification. The device operates with minimal technician involvement and complete automation of all procedural steps.

Device Class : 1

Duns Number: 561011079

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

Automated Nucleic Acids Extraction System ANDiS 360 - 06973685478010 Catalog Number : 3000000000044

Device Description : The device is an automated system, used for extraction and purification of nucle The device is an automated system, used for extraction and purification of nucleic acid from clinical specimens.

Device Class : 1

Duns Number: 561011079

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

Automated Nucleic Acids Extraction System ANDiS 396 - 06973685478027 Catalog Number : 3000000000414

Device Description : The device is used for extraction and purification of nucleic acid in clinical samples.

Device Class : 1

Duns Number: 561011079

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

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