DSQ Alert™ Parechovirus v2.0 Probe Mix ASR M800759
GUDID 03661540952708
DSQ Alert Parechovirus v2.0 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the 5’-untranslated region (5’-UTR) of the parechovirus RNA genome. The mix consists of a total of 1.3 nmol of probe per vial in a 1X TE buffer solution. The probe is labeled with the AP593 fluorophore and has an excitation wavelength maximum of 593 nm and an emission wavelength maximum of 613 nm.
Elitechgroup Mdx LLC
Human parechovirus (HPeV) nucleic acid IVD, reagent| Primary Device ID | 03661540952708 |
| NIH Device Record Key | 6f507667-f9ec-419e-89b8-d899535c7d1f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DSQ Alert™ Parechovirus v2.0 Probe Mix ASR |
| Version Model Number | M800759 |
| Catalog Number | M800759 |
| 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 |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03661540952708 [Primary] |
FDA Product Code
| MVU | Reagents, Specific, Analyte |
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 | 2023-10-13 |
| Device Publish Date | 2023-10-05 |
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 | 2023-10-13DSQ Alert Parechovirus v2.0 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the 5’-untranslated region (5’-UTR) of the parechovirus RNA genome. The mix consists of a total of 1.3 nmol of probe per vial in a 1X TE buffer solution. The probe is labeled with the AP593 fluorophore and has an excitation wavelength maximum of 593 nm and an emission wavelength maximum of 613 nm. |
| 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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