Molecular Transport Media (MTM) 3ml

Basic Information

• Brand Name: Molecular Transport Media (MTM) 3ml
• Primary DI: 07898996204655
• Version / Model: MEI00211
• Catalog Number: MEI00211
• Company Name: A. L. B. LUZ
• Labeler DUNS: 905130480
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-29
• Public Version: 1
• Public Version Date: 2024-09-06
• Public Version Status: New
• Public Device Record Key: 5cba46be-6d59-4432-b3b7-5699a2648541

Device Description

The Molecular Transport Media is intended for the stabilization, transportation, and direct lysis of infectious unprocessed nasopharyngeal samples suspected of containing SARS COV-2 virus RNA. These devices can be used for the collection transport and storage of specimens at 15-35 °C. Specimens collected and stored in a Molecular Transport Media are suitable for use with legally marketed molecular diagnostic devices.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: Yes
• 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
QBD	Microbial Nucleic Acid Storage And Stabilization Device	Microbiology	866.2950	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61164	Oral/upper respiratory tract specimen collection kit	A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for subsequent laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture]. The kit consists of a non-suctioning sampling/collection tool(s) [e.g., swab, brush, spatula, saliva collection mouthpiece/funnel] and a covered specimen receptacle with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07898996204655	GS1
Package	17898996204652	GS1		50	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K233324	000