DSQ Alert® HT Pneumocystis jirovecii Primer Mix

Primary DI
03661540953149
Brand
DSQ Alert® HT Pneumocystis jirovecii Primer Mix
Company
Elitechgroup Mdx LLC
Model
M800849
Catalog number
M800849
Device description
Product DescriptionDSQ Alert® HT Pneumocystis jirovecii Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the large subunit ribosomal RNA gene of Pneumocystis jirovecii. The mix consists of a total of 100 nmol of primers per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The primers target a 144 bp region of the large subunit ribosomal RNA gene of Pneumocystis jirovecii. 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 or equal to -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.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
2026-05-12
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
03661540953149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661540953149036615409531493661540953149

GMDN Terms#

Term, Definition table
TermDefinition
Pneumocystis jirovecii 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 the fungus Pneumocystis jirovecii (formerly known as P. carinii) 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

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

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