FDA.reportPublic FDA data

DSQ Alert BK Virus v3.0 Primer Mix

Primary DI
03661540952746
Brand
DSQ Alert BK Virus v3.0 Primer Mix
Company
Elitechgroup Mdx LLC
Model
M800726
Device description
DSQ Alert BK Virus ASR v3.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acids from the BK Virus. The mix consists of a total of 6.4 nmol of primers per vial in a 1X TE buffer solution. The primers target a 72 bp region of the major capsid protein VP1 gene of the BK Virus.The 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
2024-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
03661540952746PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661540952746036615409527463661540952746

GMDN Terms#

Term, Definition table
TermDefinition
BK virus (BKV) 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 BK virus (BKV) in a clinical specimen, using a nucleic acid technique (NAT).

Sterilization Methods#

Method table
Method

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661540953170DSQ Alert HT Adenovirus Primer Mix ASRM800860M8008602026-08-07
03661540953187DSQ Alert HT Adenovirus Probe Mix ASRM800861M8008612026-08-07
03661540953217DSQ Alert Hepatitis E Primer Mix ASRM800854M8008542026-08-07
03661540953224DSQ Alert Hepatitis E Probe Mix ASRM800855M8008552026-08-07
03661540953279DSQ Alert Mycoplasma pneumoniae Primer Mix ASRM800867M8008672026-08-07
03661540953286DSQ Alert Mycoplasma pneumoniae Probe Mix ASRM800868M8008682026-08-07
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

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Primary DI, Brand, Company table
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03661540953224DSQ Alert Hepatitis E Probe Mix ASRElitechgroup Mdx LLCMVU2026-08-07
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