AccessGUDID - DEVICE: AvertD™ Buccal Sample Collection Kit (10850009370225)

GUDID

Device Identifier (DI) Information

Brand Name: AvertD™ Buccal Sample Collection Kit
Version or Model: 12-0610-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 12-0610-01
Company Name: AUTOGENOMICS, INC

Primary DI Number: 10850009370225
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 027914535 *Terms of Use

Device Description: Buccal Sample Collection Kit for use with 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:	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?
58216	Oral/upper respiratory tract specimen collection kit IVD, clinical	A collection of devices intended exclusively for professional use to assist in the extraction/collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for in vitro diagnostic investigation. The kit consists of a non-suctioning specimen sampling/collection tool(s) [e.g., swab, brush, spatula, saliva collection mouthpiece/funnel] and a covered specimen receptacle/container(s) with or without an additive/medium [e.g., pre-rinse/irrigation solution, tartrazine colouring agent, transport microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.	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 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 895dba6a-3768-489a-9e4d-6fbcb196f31e
Public Version Date: June 10, 2024
Public Version Number: 1
DI Record Publish Date: May 31, 2024