ELITe InGenius® SP 200 Consumable Set

FDA UDI

Class II (US FDA UDI)

by Elitechgroup Inc.

Identity

Trade Name: ELITe InGenius® SP 200 Consumable Set FDA UDI
Generic Name: Nucleic acid extraction/isolation kit IVD FDA UDI
Device Name: The ELITe InGenius® SP 200 Consumable Set (Catalog number INT032CS) provides consumables to be used with ELITe InGenius® SP 200 (Catalog number INT032SP200) extraction cartridge for nucleic acid extraction from biological samples, in association with the ELITe InGenius® instrument (Catalog number INT030-K). ELITe InGenius system, is a fully automated molecular diagnostics system performing extraction, purification, amplification and detection. ELITe InGenius® SP 200 Consumable Set is FDA cleared only for use in association with HSV 1&2 ELITe MGB® Assay FDA UDI
Model / Reference: INT032CS FDA UDI
Description: The ELITe InGenius® SP 200 Consumable Set (Catalog number INT032CS) provides consumables to be used with ELITe InGenius® SP 200 (Catalog number INT032SP200) extraction cartridge for nucleic acid extraction from biological samples, in association with the ELITe InGenius® instrument (Catalog number INT030-K). ELITe InGenius system, is a fully automated molecular diagnostics system performing extraction, purification, amplification and detection. ELITe InGenius® SP 200 Consumable Set is FDA cleared only for use in association with HSV 1&2 ELITe MGB® Assay FDA UDI

Identifiers

Primary DI / UDI-DI: 03661540900044 FDA UDI
510(k) Number: K180559 FDA UDI
FDA Product Code: OOI FDA UDI
GMDN Term: Nucleic acid extraction/isolation kit IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.2570 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

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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

ELITe InGenius® SP 200 Consumable Set by Elitechgroup Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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
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VIRCLIA® EXTRACTION SOLUTION — Vircell, S.L · Class A
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MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A

Cleared under the same submission

K180559 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Elitechgroup Inc.

Sources (1)

FDA UDI 0e292826-8af3-49e2-bfbd-2a2c78760131 34 fields · synced May 30, 2026