Home GUDID 03661540953279 DSQ Alert Mycoplasma pneumoniae Primer Mix ASR
Primary DI 03661540953279
Brand DSQ Alert Mycoplasma pneumoniae Primer Mix ASR
Company Elitechgroup Mdx LLC
Model M800867
Catalog number M800867
Device description Product Description DSQ Alert® Mycoplasma pneumoniae Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the ORF6 region of Mycoplasma pneumoniae. The mix consists of a total of 1.6 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 75 bp region of the ORF6 of Mycoplasma pneumoniae. Each product lot will go through functional testing with an approved test method. Storage and Handling Requirements The reagent contained in this package shall be shipped on dry ice, be protected from light and stored at less or equal to -10°C 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 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
Published 2026-08-07
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true
Product Codes# Code, Name table Code Name MVU Reagents, Specific, Analyte
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MVU Reagents, Specific, Analyte Pathology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 03661540953279 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 03661540953279 03661540953279 3661540953279
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 0 0
Regulatory Flags# DUNS number 117458512 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 03661540952777 MGB Alert® BKV ASR v3.0 Primer Mix M800732 2026-11-05 03661540953194 MGB Alert® Full Process Control FPC1 M800842 M800842 2026-11-05 03661540953200 MGB Alert® Full Process Control FPC2 M800843 M800842 2026-11-05 03661540953330 DSQ Alert® Borrelia Primer Mix ASR M800869 M800869 2026-11-05 03661540953347 DSQ Alert® Borrelia Probe Mix ASR M800870 M800870 2026-11-05 03661540953217 DSQ Alert Hepatitis E Primer Mix ASR M800854 M800854 2026-08-07 03661540953224 DSQ Alert Hepatitis E Probe Mix ASR M800855 M800855 2026-08-07 03661540952319 MGB Alert® BKV ASR v3.0 Primer Mix M800732 2022-09-30 03661540953170 DSQ Alert HT Adenovirus Primer Mix ASR M800860 M800860 2026-08-07 03661540953187 DSQ Alert HT Adenovirus Probe Mix ASR M800861 M800861 2026-08-07 03661540953286 DSQ Alert Mycoplasma pneumoniae Probe Mix ASR M800868 M800868 2026-08-07 03661540953149 DSQ Alert® HT Pneumocystis jirovecii Primer Mix M800849 M800849 2026-05-12 03661540953156 DSQ Alert® HT Pneumocystis jirovecii Probe Mix M800850 M800850 2026-05-12 03661540953118 DSQ Alert Measles Primer Mix ASR, 48 rxn M800845 M800845 2026-03-24 03661540953125 DSQ Alert Measles Probe Mix ASR, 48 rxn M800846 M800846 2026-03-24 03661540953132 DSQ Alert RNase P Primer Mix ASR 48 rxn M800847 M800847 2026-03-24 03661540953163 DSQ Alert RNase P Probe Mix ASR 48 rxn M800848 M800848 2026-03-24 03661540952722 DSQ Alert HHV7 Primer Mix ASR M800766 M800766 2025-10-14 03661540952739 DSQ Alert HHV7 Probe Mix ASR M800767 M800767 2025-10-14 03661540950001 MRSA/SA ELITe MGB M800346 2016-10-13
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