Atida Viral Transport Medium (Non-inactivated Type)

Basic Information

• Brand Name: Atida Viral Transport Medium (Non-inactivated Type)
• Primary DI: 00810164510822
• Version / Model: Q01-VTM-US
• Company Name: ACESO LABORATORIES INC.
• Labeler DUNS: 003099455
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-23
• Public Version: 1
• Public Version Date: 2026-03-31
• Public Version Status: New
• Public Device Record Key: b1c4b422-d072-42e6-80dd-53a6f325dd74

Device Description

1T

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JSM	Culture Media, Non-Propagating Transport	Microbiology	866.2390	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62392	Oral/respiratory tract specimen container IVD, additive/medium	A covered receptacle containing an additive and/or medium [e.g., saline, sodium azide, buffer solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)] intended to be used in the home and clinical settings for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, oropharyngeal, and/or lower respiratory tract specimen (e.g., sputum) [excluding breath specimen], for in vitro diagnostic investigation (e.g., COVID-19 screening). It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810164510822	GS1

Premarket Submissions

Submission Number	Supplement Number
K242576	000