Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24)

FDA UDI

Class I (US FDA UDI)

by Vela Operations Singapore Pte. Ltd.

Identity

Trade Name: Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24) FDA UDI
Generic Name: Nucleic acid extraction/isolation kit IVD FDA UDI
Device Name: The Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24) is used for magnetic beads-based nucleic acid extraction from virus in biological specimens. The kit is intended for in vitro diagnostic use. FDA UDI
Model / Reference: 300395 FDA UDI
Description: The Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24) is used for magnetic beads-based nucleic acid extraction from virus in biological specimens. The kit is intended for in vitro diagnostic use. FDA UDI

Identifiers

Catalog Number: 300395 FDA UDI
Primary DI / UDI-DI: 08885013958171 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

FDA UDI

Category: Nucleic acid extraction/isolation kit IVD

Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24) by Vela Operations Singapore Pte. Ltd. — 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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Nucleic Acid Extraction Kit — Shandong Bohong Gene Technology Co., Ltd. · Class A
HPLC column — Immundiagnostik AG · Class A
VIRCLIA® EXTRACTION SOLUTION — Vircell, S.L · Class A
ViraSens Total Nucleic Acid Purification Kit — Vitrosens Biotechnology Inc. · Class A
Nucleic Acid Extraction Kit — Bioteke Corporation (Wuxi) Co., Ltd. · Class A
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: Vela Operations Singapore Pte. Ltd.

Sources (1)

FDA UDI d5a0c636-1812-454a-a719-c164b653d216 34 fields · synced Jun 8, 2026