Device
Product Description
Manufacturer
Elitechgroup Mdx LLC
Model: M800850 Catalog: M800850 DI: 03661540953156 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: No OTC: No
First Published: 2026-05-12 Current Version: 2026-05-20
Description
Product Description DSQ Alert® HT Pneumocystis jirovecii Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the large subunit ribosomal RNA gene of Pneumocystis jirovecii The mix consists of a total of 24.5 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 495 nm and an emission wavelength maximum of 521 nm. Each product lot will go through functional testing with an approved test method. Storage and Handling Requirements The reagent contained in this package should 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 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.
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: d50b2f18-cb54-4121-adbe-a32a21b9bcea
Distribution Status: In Commercial Distribution
DUNS Number: 117458512
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: Yes
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 03661540953156
Type: Primary
Issuing Agency: GS1
GMDN
Code: 62755
Name: Pneumocystis jirovecii nucleic acid IVD, kit, nucleic acid technique (NAT)
Definition:
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).
FDA Product Codes
MVU
Reagents, Specific, Analyte
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit: Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value: -30
Storage Handling - Storage Handling High - @attributes - Unit: Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value: -10
Storage Handling - Storage Handling Type: Storage Environment Temperature