ANDiS Viral RNA Auto Extraction & Purification Kit

FDA UDI

Class I (US FDA UDI)

by 3D Biomedicine Science & Technology Co., Limited

Identity

Trade Name: ANDiS Viral RNA Auto Extraction & Purification Kit FDA UDI
Generic Name: Nucleic acid extraction/isolation kit IVD FDA UDI
Device Name: The ANDiS Viral RNA Auto Exttaction & Purification Kit is a system that uses automatic magnetic beads technology for isolation and purification of viral RNA from biological specimens. The product is intended to be used by professional users, such as technicians and physicians who are trained in molecular biological techniques. The ANDiS Viral RNA Auto Extraction & Purification Kit is intennded for in vitro diagnostic use. FDA UDI
Model / Reference: 64 Tests/Kit FDA UDI
Description: The ANDiS Viral RNA Auto Exttaction & Purification Kit is a system that uses automatic magnetic beads technology for isolation and purification of viral RNA from biological specimens. The product is intended to be used by professional users, such as technicians and physicians who are trained in molecular biological techniques. The ANDiS Viral RNA Auto Extraction & Purification Kit is intennded for in vitro diagnostic use. FDA UDI

Identifiers

Catalog Number: 3103010046 FDA UDI
Primary DI / UDI-DI: 06973685471004 FDA UDI
FDA Product Code: JJH FDA UDI
GMDN Term: Nucleic acid extraction/isolation kit IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2310 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Nucleic acid extraction/isolation kit IVD

ANDiS Viral RNA Auto Extraction & Purification Kit by 3D Biomedicine Science & Technology Co., Limited — Class I — FDA UDI — listed in FDA GUDID

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Also classified as Nucleic acid extraction/isolation kit IVD.

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: 3D Biomedicine Science & Technology Co., Limited

Sources (1)

FDA UDI 56068e3d-e8ae-4d60-8226-e5138af433df 34 fields · synced May 30, 2026