DSQ Alert® HT JCV Primer Mix ASR M800813
GUDID 03661540952821
DSQ Alert® HT JCV Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the gene A in large tumor antigen region of JC Virus (Human polyomavirus 2). The mix consists of a total of 39.2 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 78 bp region of the gene A of JCV. Each product lot will go through functional testing with an approved test method. The reagent contained in this package shall be shipped on dry ice, be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles
Elitechgroup Mdx LLC
JC virus (JCV) nucleic acid IVD, kit, nucleic acid technique (NAT)| Primary Device ID | 03661540952821 |
| NIH Device Record Key | 0c450984-7f36-42bd-9bd7-7a388e96075c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DSQ Alert® HT JCV Primer Mix ASR |
| Version Model Number | M800813 |
| Catalog Number | M800813 |
| 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 | true |
| 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 | 1-833-227-3400 |
| mdx@elitechgroup.com | |
| Phone | 1-833-227-3400 |
| mdx@elitechgroup.com | |
| Phone | 1-833-227-3400 |
| mdx@elitechgroup.com | |
| Phone | 1-833-227-3400 |
| mdx@elitechgroup.com | |
| Phone | 1-833-227-3400 |
| mdx@elitechgroup.com | |
| Phone | 1-833-227-3400 |
| mdx@elitechgroup.com | |
| Phone | 1-833-227-3400 |
| mdx@elitechgroup.com | |
| Phone | 1-833-227-3400 |
| mdx@elitechgroup.com | |
| Phone | 1-833-227-3400 |
| mdx@elitechgroup.com | |
| Phone | 1-833-227-3400 |
| mdx@elitechgroup.com | |
| Phone | 1-833-227-3400 |
| mdx@elitechgroup.com | |
| Phone | 1-833-227-3400 |
| mdx@elitechgroup.com | |
| Phone | 1-833-227-3400 |
| mdx@elitechgroup.com | |
| Phone | 1-833-227-3400 |
| mdx@elitechgroup.com | |
| Phone | 1-833-227-3400 |
| mdx@elitechgroup.com | |
| Phone | 1-833-227-3400 |
| mdx@elitechgroup.com | |
| Phone | 1-833-227-3400 |
| mdx@elitechgroup.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03661540952821 [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 | 2025-03-14 |
| Device Publish Date | 2025-03-06 |
Devices Manufactured by Elitechgroup Mdx LLC
| 03661540952821 - DSQ Alert® HT JCV Primer Mix ASR | 2025-03-14DSQ Alert® HT JCV Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the gene A in large tumor antigen region of JC Virus (Human polyomavirus 2). The mix consists of a total of 39.2 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 78 bp region of the gene A of JCV. Each product lot will go through functional testing with an approved test method. The reagent contained in this package shall be shipped on dry ice, be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles |
| 03661540952821 - DSQ Alert® HT JCV Primer Mix ASR | 2025-03-14 DSQ Alert® HT JCV Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed |
| 03661540952838 - DSQ Alert® HT JCV Probe Mix ASR | 2025-03-14 Product Description DSQ Alert® HT JCV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligo |
| 03661540952845 - DSQ Alert HT Norovirus GI Primer Mix ASR | 2025-03-14 Product Description DSQ Alert® HT Norovirus GI Primer Mix is an analyte specific reagent that contains chemically synthesized D |
| 03661540952852 - DSQ Alert® HT Norovirus GI Probe Mix ASR | 2025-03-14 Product Description DSQ Alert® HT Norovirus GI Probe Mix is an analyte specific reagent that contains a chemically synthesized |
| 03661540952869 - DSQ Alert HT Norovirus GII Primer Mix ASR | 2025-03-14 Product Description DSQ Alert® HT Norovirus GII Primer Mix is an analyte specific reagent that contains chemically synthesized |
| 03661540952876 - DSQ Alert® HT Norovirus GII Probe Mix ASR | 2025-03-14 Product Description DSQ Alert® HT Norovirus GII Probe Mix is an analyte specific reagent that contains a chemically synthesized |
| 03661540952883 - DSQ Alert™ HT HAV Primer Mix ASR | 2025-03-14 Product Description DSQ Alert® HT HAV Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligon |
| 03661540952890 - DSQ Alert® HT HAV Probe Mix ASR | 2025-03-14 Product Description DSQ Alert® HT HAV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligo |
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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