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Automated Nucleic Acids Extraction System ANDiS 350

FDA UDI

Class I (US FDA UDI)

by 3D Biomedicine Science & Technology Co., Limited

Identity

Trade Name
Automated Nucleic Acids Extraction System ANDiS 350 FDA UDI
Generic Name
Nucleic acid sample preparation instrument IVD FDA UDI
Device Name
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. FDA UDI
Model / Reference
ANDiS 350 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
3000000000115 FDA UDI
Primary DI / UDI-DI
06973685478003 FDA UDI
FDA Product Code
JJH FDA UDI
GMDN Term
Nucleic acid sample preparation instrument IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2310 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Automated Nucleic Acids Extraction System ANDiS 350 by 3D Biomedicine Science & Technology Co., Limited — Class I — FDA UDI — listed in FDA GUDID

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
3D Biomedicine Science & Technology Co., Limited

Sources (1)

  • FDA UDI ccc543e9-b850-466f-904c-fdd17d6a2369 35 fields · synced May 30, 2026