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, Test Kit, Cartridges: Contains substances for DNA extraction, PCR amplification, and detection of the CYP2C19 alleles, in three separate tubes. Each tube is specific for the detection of one of the three CYP2C19 loci. One box of Test Kit, cartridges contains 20 cartridges; one cartridge per pouch. The Genomadix Cube CYP2C19 Test is indicated for use with the Genomadix Cube CYP2C19 Platform. FDA UDI
Model / Reference: 2 FDA UDI
Description: Genomadix Cube CYP2C19 System, Test Kit, Cartridges: Contains substances for DNA extraction, PCR amplification, and detection of the CYP2C19 alleles, in three separate tubes. Each tube is specific for the detection of one of the three CYP2C19 loci. One box of Test Kit, cartridges contains 20 cartridges; one cartridge per pouch. The Genomadix Cube CYP2C19 Test is indicated for use with the Genomadix Cube CYP2C19 Platform. FDA UDI

Identifiers

Primary DI / UDI-DI: ASM00101 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

Yes

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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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 6f4a49ee-6051-43bb-9115-c0c67f7b1c63 35 fields · synced Jun 8, 2026