ELITe InGenius® SP 200

FDA UDI

Class II (US FDA UDI)

by Elitechgroup Inc.

Identity

Trade Name: ELITe InGenius® SP 200 FDA UDI
Generic Name: Nucleic acid extraction/isolation kit IVD FDA UDI
Device Name: The product ELITe InGenius® SP 200 extraction cartridge (catalog number INT032SP200) provides reagents used in association with the ELITe InGenius® instrument (catalog number INT030-K) to perform extractions and purification of nucleic acids. ELITe InGenius system, is a fully automated molecular diagnostics system performing extraction, purification, amplification and detection. ELITe InGenius SP 200 is FDA cleared only for use in association with ELITe InGenius® (code INT030-K) instrument and HSV1&2 ELITe MGB® Assay. FDA UDI
Model / Reference: INT032SP200 FDA UDI
Description: The product ELITe InGenius® SP 200 extraction cartridge (catalog number INT032SP200) provides reagents used in association with the ELITe InGenius® instrument (catalog number INT030-K) to perform extractions and purification of nucleic acids. ELITe InGenius system, is a fully automated molecular diagnostics system performing extraction, purification, amplification and detection. ELITe InGenius SP 200 is FDA cleared only for use in association with ELITe InGenius® (code INT030-K) instrument and HSV1&2 ELITe MGB® Assay. FDA UDI

Identifiers

Catalog Number: INT032SP200 FDA UDI
Primary DI / UDI-DI: 03661540900020 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 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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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 23b8c9af-326f-44f6-8b9c-792a3253798c 35 fields · synced Jun 1, 2026