MGB Alert HDV Probe Mix ASR

Primary DI
03661540952913
Brand
MGB Alert HDV Probe Mix ASR
Company
Elitechgroup Mdx LLC
Model
M800818
Catalog number
M800818
Device description
Product DescriptionMGB 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 RequirementsThe 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 PrecautionsCarefully 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.
Published
2025-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVUReagents, Specific, Analyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661540952913PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661540952913036615409529133661540952913

GMDN Terms#

Term, Definition table
TermDefinition
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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-30 Degrees Celsius-10 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-833-227-3400mdx@elitechgroup.com

Regulatory Flags#

DUNS number
117458512
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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Primary DI, Brand, Model table
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03661540953118DSQ Alert Measles Primer Mix ASR, 48 rxnM800845M8008452026-03-24
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03661540953132DSQ Alert RNase P Primer Mix ASR 48 rxnM800847M8008472026-03-24
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03661540950278MGB Alert Platinum Master Mix-48 rxnM800599M8005992020-09-15
03661540951725MGB Alert 2X PCR Master Mix 480 rxnM800547M8005472020-09-15
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