MGB Alert HDV Probe Mix ASR

Basic Information

• Brand Name: MGB Alert HDV Probe Mix ASR
• Primary DI: 03661540952913
• Version / Model: M800818
• Catalog Number: M800818
• Company Name: Elitechgroup Mdx LLC
• Labeler DUNS: 117458512
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-15
• Public Version: 1
• Public Version Date: 2025-10-23
• Public Version Status: New
• Public Device Record Key: 2a1b9751-32d6-4f3a-972f-b803925429c3

Device Description

Product Description MGB Alert® HDV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the Hepatitis Delta Virus RNA. The mix consists of a total of 0.6 nmol of Pleiades probe per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The probe is labeled with the FAM fluorophore and has an excitation wavelength maximum of 496 nm and an emission wavelength maximum of 517 nm. Each product lot will go through functional testing with an approved test method. Storage and Handling Requirements The reagent contained in this package shall be shipped on dry ice, be protected from light and stored at less than -10 degrees Celsius when received. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles. Warnings and Precautions Carefully read this entire package insert. - The operator must be trained to perform high complexity work and avoid distractions which may lead to errors. - Use general precautions and wear appropriate personal protective equipment when handling the reagents. - Do not eat, drink, or smoke in designated work areas. - Wash hands thoroughly after handling reagents. - Prevent reagent carryover by working in a nuclease-free area keeping one tube open at a time during reagent preparation and PCR setup. Completed PCR tubes or sealed plates should not be opened. - Dispose of all material that has come into contact with specimens and reagents in accordance with applicable national, international, and regional regulations.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
MVU	Reagents, Specific, Analyte	Pathology	864.4020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48400	Hepatitis D virus nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Hepatitis D virus nucleic acid in a clinical specimen, using a nucleic acid technique (NAT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03661540952913	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -30 – -10 Degrees Celsius