DSQ Alert™ MS2-ICB-1 Internal Control Set M800707
GUDID 03661540952098
The DSQ Alert MS2-ICB-1 Internal Control Set consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The MS2-ICB-1 Internal Control Set can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. This set is not intended to monitor other real-time PCR processes.
Elitechgroup Mdx LLC
Exogenous DNA/RNA internal control IVD, kit| Primary Device ID | 03661540952098 |
| NIH Device Record Key | 4b4f6953-042b-442c-955e-770a02aad59c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DSQ Alert™ MS2-ICB-1 Internal Control Set |
| Version Model Number | M800707 |
| Catalog Number | M800707 |
| Company DUNS | 117458512 |
| Company Name | Elitechgroup Mdx LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03661540952098 [Primary] |
FDA Product Code
| OLD | Internal Polymerase Chain Reaction Control, Not Assay Specific |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-29 |
| Device Publish Date | 2023-09-21 |
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 | 2024-08-06 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 ASR | 2024-07-24 DSQ Alert™ HT HDV Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed |
| 03661540952814 - DSQ Alert HT Probe Mix ASR | 2024-07-24 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 Mix | 2024-05-23 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 rxns | 2024-05-23 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 ASR | 2023-10-13 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 ASR | 2023-10-13 DSQ Alert Parechovirus v2.0 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide |
Trademark Results [DSQ Alert]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DSQ ALERT 98144462 not registered Live/Pending |
ELITechGroup MDx LLC 2023-08-22 |
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