ELITe InGenius® Waste Box

FDA UDI

Class II (US FDA UDI)

by Elitechgroup Inc.

Identity

Trade Name: ELITe InGenius® Waste Box FDA UDI
Generic Name: Laboratory waste receptacle IVD FDA UDI
Device Name: The product «ELITe InGenius® Waste Box» (Catalog code F2102-000) provides disposable plastic boxes for collecting tip waste generated during the protocol run for extraction from biological samples, realtime set up in association with the «ELITe InGenius®» a fully automated sample-to-result instrument (Catalog code INT030-K). ELITe InGenius® Waste Box is FDA cleared only for use in association with ELITe InGenius® (Catalog code INT030-K) and HSV1&2 ELITe MGB® Assay. FDA UDI
Model / Reference: F2102-000 FDA UDI
Description: The product «ELITe InGenius® Waste Box» (Catalog code F2102-000) provides disposable plastic boxes for collecting tip waste generated during the protocol run for extraction from biological samples, realtime set up in association with the «ELITe InGenius®» a fully automated sample-to-result instrument (Catalog code INT030-K). ELITe InGenius® Waste Box is FDA cleared only for use in association with ELITe InGenius® (Catalog code INT030-K) and HSV1&2 ELITe MGB® Assay. FDA UDI

Identifiers

Catalog Number: F2102-000 FDA UDI
Primary DI / UDI-DI: 03661540900051 FDA UDI
510(k) Number: K180559 FDA UDI
FDA Product Code: OOI FDA UDI
GMDN Term: Laboratory waste receptacle 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: Laboratory waste receptacle IVD

ELITe InGenius® Waste Box by Elitechgroup Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laboratory waste receptacle IVD.

Alinity m — Abbott Molecular · Class II
Alinity m — Abbott Molecular · Class II
Curaplex — BOUND TREE MEDICAL, LLC · Class I
Curaplex — BOUND TREE MEDICAL, LLC · Class II
NovaSeq™ 6000Dx Library Tube — Illumina, Inc. · Class I
Curaplex — BOUND TREE MEDICAL, LLC · Class II
Curaplex — BOUND TREE MEDICAL, LLC · Class I
Disposable Waste Container D513 REF 905-802 — Radiometer Medical ApS · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Elitechgroup Inc.

Sources (1)

FDA UDI f0b5e366-bfd7-49a3-9ce2-5689c67f7ef2 35 fields · synced May 30, 2026