FDA.reportPublic FDA data

DSQ Alert® HT Norovirus GII Probe Mix ASR

Primary DI
03661540952876
Brand
DSQ Alert® HT Norovirus GII Probe Mix ASR
Company
Elitechgroup Mdx LLC
Model
M800822
Catalog number
M800822
Device description
Product DescriptionDSQ Alert® HT Norovirus GII Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences in RNA-dependent RNA polymerase (RdRp) region of Noro virus Genogroup GII. The mix consists of a total of 8.3 nmol of DSQ 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 should be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.
Published
2025-03-06
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
03661540952876PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661540952876036615409528763661540952876

GMDN Terms#

Term, Definition table
TermDefinition
Norovirus 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 nucleic acid from Norovirus in a clinical specimen, using a nucleic acid technique (NAT).

Storage And Handling#

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

Sterilization Methods#

Method table
Method

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661540953149DSQ Alert® HT Pneumocystis jirovecii Primer Mix M800849M8008492026-05-12
03661540953156DSQ Alert® HT Pneumocystis jirovecii Probe MixM800850M8008502026-05-12
03661540953118DSQ Alert Measles Primer Mix ASR, 48 rxnM800845M8008452026-03-24
03661540953125DSQ Alert Measles Probe Mix ASR, 48 rxnM800846M8008462026-03-24
03661540953132DSQ Alert RNase P Primer Mix ASR 48 rxnM800847M8008472026-03-24
03661540953163DSQ Alert RNase P Probe Mix ASR 48 rxnM800848M8008482026-03-24
03661540952722DSQ Alert HHV7 Primer Mix ASRM800766M8007662025-10-14
03661540952739DSQ Alert HHV7 Probe Mix ASRM800767M8007672025-10-14
03661540950001MRSA/SA ELITe MGBM8003462016-10-13
03661540951411MGB Alert Internal Control Set IC2-480 rxn8003628003622020-09-15
03661540951862MGB Alert®Internal Control 1C Set, 480 rxn8003618003612020-09-15
03661540951336MGB Alert HHV-6 Primer Mix ASR - 480 rxn8003388003382020-09-14
03661540951770MGB Alert® Chlamydophila Pneumoniae Probe Mix ASR - 48 Reactions8004348004342020-09-08
03661540952906MGB Alert® HDV Primer Mix ASRM800817M8008172025-10-15
03661540952913MGB Alert HDV Probe Mix ASRM800818M8008182025-10-15
03661540952517MGB Alert 2X ELITaq Master Mix, 48rxnM800809M8008092023-02-03
03661540952524MGB Alert ELITaq Master Mix, 480 rxnM800810M8008102023-02-03
03661540950278MGB Alert Platinum Master Mix-48 rxnM800599M8005992020-09-15
03661540951725MGB Alert 2X PCR Master Mix 480 rxnM800547M8005472020-09-15
03661540951756MGB Alert One-Step Reverse Transcriptase PCR Master Mix M800689M8006892020-09-15

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