DSQ Alert Internal Control set IC1 M800734

GUDID 03661540952791

The DSQ Alert Internal Control Set IC1 contains the MGB Alert IC1 DNA Template, the DSQ Alert IC1 v3.0 Primers, and the DSQ Alert IC1 Probe. When used as intended, the Internal Control Set IC1 DSQ will detect systemic variation that may arise during the nucleic acid extraction and amplification processes associated with real-time PCR assays. The reagent contained in this package should be protected from light and stored at less or equal to -10 degrees Celsius. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaws.

Elitechgroup Mdx LLC

Nucleic acid amplification primer IVD
Primary Device ID03661540952791
NIH Device Record Key1d81943c-677e-44d4-86c4-d420e9850b1e
Commercial Distribution StatusIn Commercial Distribution
Brand NameDSQ Alert Internal Control set IC1
Version Model NumberM800734
Catalog NumberM800734
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 Usefalse
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

Phone(833) 227-3400
Emailmdx@elitechgroup.com
Phone(833) 227-3400
Emailmdx@elitechgroup.com
Phone(833) 227-3400
Emailmdx@elitechgroup.com
Phone(833) 227-3400
Emailmdx@elitechgroup.com
Phone(833) 227-3400
Emailmdx@elitechgroup.com
Phone(833) 227-3400
Emailmdx@elitechgroup.com
Phone(833) 227-3400
Emailmdx@elitechgroup.com
Phone(833) 227-3400
Emailmdx@elitechgroup.com
Phone(833) 227-3400
Emailmdx@elitechgroup.com
Phone(833) 227-3400
Emailmdx@elitechgroup.com
Phone(833) 227-3400
Emailmdx@elitechgroup.com
Phone(833) 227-3400
Emailmdx@elitechgroup.com
Phone(833) 227-3400
Emailmdx@elitechgroup.com
Phone(833) 227-3400
Emailmdx@elitechgroup.com
Phone(833) 227-3400
Emailmdx@elitechgroup.com
Phone(833) 227-3400
Emailmdx@elitechgroup.com
Phone(833) 227-3400
Emailmdx@elitechgroup.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103661540952791 [Primary]

FDA Product Code

OLDInternal Polymerase Chain Reaction Control, Not Assay Specific

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-06
Device Publish Date2024-07-29

Devices Manufactured by Elitechgroup Mdx LLC

03661540952760 - DSQ Alert® Internal Control set IC1 2024-11-01 The DSQ Alert Internal Control Set IC1 contains the MGB Alert IC1 DNA Template, the DSQ Alert IC1 v3.0 Primers, and the MGB Aler
03661540952791 - DSQ Alert Internal Control set IC1 2024-08-06The DSQ Alert Internal Control Set IC1 contains the MGB Alert IC1 DNA Template, the DSQ Alert IC1 v3.0 Primers, and the DSQ Alert IC1 Probe. When used as intended, the Internal Control Set IC1 DSQ will detect systemic variation that may arise during the nucleic acid extraction and amplification processes associated with real-time PCR assays. The reagent contained in this package should be protected from light and stored at less or equal to -10 degrees Celsius. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaws.
03661540952791 - DSQ Alert Internal Control set IC1 2024-08-06 The DSQ Alert Internal Control Set IC1 contains the MGB Alert IC1 DNA Template, the DSQ Alert IC1 v3.0 Primers, and the DSQ Aler
03661540952807 - DSQ Alert HT Primer Mix ASR2024-07-24 DSQ Alert™ HT HDV Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed
03661540952814 - DSQ Alert HT Probe Mix ASR2024-07-24 DSQ Alert™ HT HDV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed
03661540952746 - DSQ Alert BK Virus v3.0 Primer Mix2024-05-23 DSQ Alert BK Virus ASR v3.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acids fr
03661540952753 - DSQ Alert BKV ASR v3.0 Probe Mix, 48 rxns2024-05-23 DSQ Alert® BK Virus ASR v3.0 Probe Mix contains chemically synthesized DNA oligonucleotides designed to detect nucleic acids fr
03661540952692 - DSQ Alert™ Parechovirus v2.0 Primer Mix ASR2023-10-13 DSQ Alert Parechovirus v2.0 Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides
03661540952708 - DSQ Alert™ Parechovirus v2.0 Probe Mix ASR2023-10-13 DSQ Alert Parechovirus v2.0 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide

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