Genomadix Cube CYP2C19

FDA UDI

Class II (US FDA UDI)

by Genomadix, Inc.

Identity

Trade Name: Genomadix Cube CYP2C19 FDA UDI
Generic Name: Nucleic acid amplification mastermix kit IVD FDA UDI
Device Name: Genomadix Cube CYP2C19 System, Control Kit, Cartridges. Box of 10 controls, reagents. FDA UDI
Model / Reference: 2 FDA UDI
Description: Genomadix Cube CYP2C19 System, Control Kit, Cartridges. Box of 10 controls, reagents. FDA UDI

Identifiers

Primary DI / UDI-DI: G257ASM000990 FDA UDI
510(k) Number: K220026 FDA UDI
FDA Product Code: NTI FDA UDI
GMDN Term: Nucleic acid amplification mastermix kit IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.3360 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

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

Yes

FDA UDI

Category: Nucleic acid amplification mastermix kit IVD

Genomadix Cube CYP2C19 by Genomadix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Nucleic acid amplification mastermix kit IVD.

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MGB Alert Platinum Master Mix with water-480rxn — ELITechGroup MDX LLC. · Class I
QIAcuityDx® Universal MasterMix Kit — Qiagen, Inc. · Class I
Spartan RX CYP2C19 System — Spartan Bioscience, Inc. · Class II

Cleared under the same submission

K220026 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: Genomadix, Inc.

Sources (1)

FDA UDI df87262a-f8da-44fb-8aca-da403f03475d 36 fields · synced May 30, 2026