AccessGUDID - DEVICE: Genomadix Cube CYP2C19, (ASM00101)

GUDID

Device Identifier (DI) Information

Brand Name: Genomadix Cube CYP2C19,
Version or Model: 2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Genomadix Inc

Primary DI Number: ASM00101
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 204354752 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60091	Nucleic acid amplification mastermix kit IVD	A collection of reagents and other associated materials [enzymes, buffers, nucleotides, magnesium chloride (MgCl2)], intended to be used in combination with sequence-specific primers, probes and/or controls (not included) to facilitate the amplification of a target nucleic acid sequence [i.e., deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)] in a clinical specimen, using a nucleic acid amplification technique [e.g., polymerase chain reaction (PCR), loop-mediated isothermal amplification (LAMP)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NTI	Drug Metabolizing Enzyme Genotyping Systems

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -80 and -15 Degrees Celsius
Special Storage Condition, Specify: Shipping box contains dry ice.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6f4a49ee-6051-43bb-9115-c0c67f7b1c63
Public Version Date: April 18, 2025
Public Version Number: 3
DI Record Publish Date: July 18, 2023