96A Automated Viral DNA/RNA Isolation Kit

FDA UDI

Class I (US FDA UDI)

by 3D Biomedicine Science & Technology Co., Limited

Identity

Trade Name: 96A Automated Viral DNA/RNA Isolation Kit FDA UDI
Generic Name: Nucleic acid extraction/isolation kit IVD FDA UDI
Device Name: 96A Automated Viral DNA/RNA Isolation Kit is intended for isolation and purification of viral DNA and RNA from biological specimens by using automatic magnetic beads technology, The purified nucleic acids can be directly used for the downstream tests. The product is intended to be used by professional users, such as laboratory personnel who has been trained. FDA UDI
Model / Reference: 96 Tests FDA UDI
Description: 96A Automated Viral DNA/RNA Isolation Kit is intended for isolation and purification of viral DNA and RNA from biological specimens by using automatic magnetic beads technology, The purified nucleic acids can be directly used for the downstream tests. The product is intended to be used by professional users, such as laboratory personnel who has been trained. FDA UDI

Identifiers

Catalog Number: 3000000000012 FDA UDI
Primary DI / UDI-DI: 06973685471356 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

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

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Manufacturing Date

FDA UDI

Category: Nucleic acid extraction/isolation kit IVD

96A Automated Viral DNA/RNA Isolation 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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MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A

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 e851f451-9b28-4e7e-8964-770152d2de41 34 fields · synced May 30, 2026