| Primary Device ID | 03661540952791 |
| NIH Device Record Key | 1d81943c-677e-44d4-86c4-d420e9850b1e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DSQ Alert Internal Control set IC1 |
| Version Model Number | M800734 |
| Catalog Number | M800734 |
| 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 | (833) 227-3400 |
| mdx@elitechgroup.com | |
| Phone | (833) 227-3400 |
| mdx@elitechgroup.com | |
| Phone | (833) 227-3400 |
| mdx@elitechgroup.com | |
| Phone | (833) 227-3400 |
| mdx@elitechgroup.com | |
| Phone | (833) 227-3400 |
| mdx@elitechgroup.com | |
| Phone | (833) 227-3400 |
| mdx@elitechgroup.com | |
| Phone | (833) 227-3400 |
| mdx@elitechgroup.com | |
| Phone | (833) 227-3400 |
| mdx@elitechgroup.com | |
| Phone | (833) 227-3400 |
| mdx@elitechgroup.com | |
| Phone | (833) 227-3400 |
| mdx@elitechgroup.com | |
| Phone | (833) 227-3400 |
| mdx@elitechgroup.com | |
| Phone | (833) 227-3400 |
| mdx@elitechgroup.com | |
| Phone | (833) 227-3400 |
| mdx@elitechgroup.com | |
| Phone | (833) 227-3400 |
| mdx@elitechgroup.com | |
| Phone | (833) 227-3400 |
| mdx@elitechgroup.com | |
| Phone | (833) 227-3400 |
| mdx@elitechgroup.com | |
| Phone | (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 | 03661540952791 [Primary] |
| OLD | Internal Polymerase Chain Reaction Control, Not Assay Specific |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-06 |
| Device Publish Date | 2024-07-29 |
| 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 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 |
| 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 |