DSQ Alert RNase P Primer Mix ASR 48 rxn M800847

GUDID 03661540953132

Product Description DSQ Alert® RNase P Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the human RNase P gene. The mix consists of a total of 0.3 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 65 bp region of the human RNase P gene. 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 than -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.

Elitechgroup Mdx LLC

Endogenous DNA/RNA internal control IVD, reagent
Primary Device ID03661540953132
NIH Device Record Keyb1c5b382-71e0-4375-9501-05a340f7e81b
Commercial Distribution StatusIn Commercial Distribution
Brand NameDSQ Alert RNase P Primer Mix ASR 48 rxn
Version Model NumberM800847
Catalog NumberM800847
Company DUNS117458512
Company NameElitechgroup Mdx LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com

Operating and Storage Conditions

Handling Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103661540953132 [Primary]

FDA Product Code

MVUReagents, Specific, Analyte

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-04-01
Device Publish Date2026-03-24

Devices Manufactured by Elitechgroup Mdx LLC

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03661540953132 - DSQ Alert RNase P Primer Mix ASR 48 rxn2026-04-01Product Description DSQ Alert® RNase P Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the human RNase P gene. The mix consists of a total of 0.3 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 65 bp region of the human RNase P gene. 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 than -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.
03661540953132 - DSQ Alert RNase P Primer Mix ASR 48 rxn2026-04-01 Product Description DSQ Alert® RNase P Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligo
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03661540952838 - DSQ Alert® HT JCV Probe Mix ASR2025-03-14 Product Description DSQ Alert® HT JCV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligo

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