| Primary Device ID | 03661540952814 |
| NIH Device Record Key | 0cb6a99c-7d04-4413-a962-c847ea17872d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DSQ Alert HT Probe Mix ASR |
| Version Model Number | M800812 |
| Catalog Number | M800812 |
| 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 |
| 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 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 03661540952814 [Primary] |
| MVU | Reagents, Specific, Analyte |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-24 |
| Device Publish Date | 2024-07-16 |
| 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 | 2024-07-24DSQ Alert™ HT HDV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the Hepatitis Delta Virus RNA. The mix consists of a total of 7.8 nmol of DSQ probe per vial in a 1X TE buffer solution. The probe is labeled with the 6-FAM fluorophore and has an excitation wavelength maximum of 496 nm and an emission wavelength maximum of 517 nm. 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. |
| 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 |
| 03661540952005 - MGB Alert HSV1 Primer Mix, 48 rxn ASR, Finished Product | 2023-09-29 MGB Alert HSV-1 Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to |
| 03661540952012 - MGB Alert HSV1 Probe Mix, 48 rxn ASR, Finished Product | 2023-09-29 MGB Alert HSV-1 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotides designed to |