AccessGUDID - DEVICE: Genomadix Cube CYP2C19 (G257ASM000990)

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: G257ASM000990
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, Control Kit, Cartridges. Box of 10 controls, reagents.

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:	No
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 [?]
K220026	000

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: df87262a-f8da-44fb-8aca-da403f03475d
Public Version Date: April 18, 2025
Public Version Number: 3
DI Record Publish Date: June 14, 2024