AccessGUDID - DEVICE: AvertD™ Amplification Mix (10850009370195)

GUDID

Device Identifier (DI) Information

Brand Name: AvertD™ Amplification Mix
Version or Model: 03-3560-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 03-3560-01
Company Name: AUTOGENOMICS, INC

Primary DI Number: 10850009370195
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 027914535 *Terms of Use

Device Description: The Amplification Mix provides the reagent for the PCR amplification of the DNA sample as part of AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA.

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:	No
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?
67125	Opioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to determine the risk of developing opioid use disorder (OUD) based on multiple disease-associated genotypes, using a nucleic acid technique (NAT). These genotypes may include, but are not limited to, variants of the methylenetetrahydrofolate reductase (MTHFR), mu-opioid receptor, galanin (GAL) and ABCB1 genes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QZH	Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P230032	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 -30 and -15 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f76ebe02-f42d-42b0-97a3-77f60972a8d3
Public Version Date: June 10, 2024
Public Version Number: 1
DI Record Publish Date: May 31, 2024