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 |
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 |
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 Issuing Agency | Device ID |
---|---|
GS1 | 03661540952098 [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 | 2023-09-29 |
Device Publish Date | 2023-09-21 |
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 |
03661540952029 - MGB Alert HSV2 Primer Mix, 48 rxn ASR, Finished Product | 2023-09-29 MGB Alert HSV-2 Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to |
03661540952036 - MGB Alert HSV2 Probe Mix, 48 rxn ASR, Finished Product | 2023-09-29 MGB Alert HSV-2 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotides designed to |
03661540952098 - DSQ Alert™ MS2-ICB-1 Internal Control Set | 2023-09-29The 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. |
03661540952098 - DSQ Alert™ MS2-ICB-1 Internal Control Set | 2023-09-29 The DSQ Alert MS2-ICB-1 Internal Control Set consists of reagents intended for use as an unassayed internal extraction and ampli |
03661540952104 - MGB Alert Enterovirus v.2.0 Primer Mix ASR, 48 rxns | 2023-09-29 DSQ Alert Enterovirus v2.0 ASR Primer Mix is an analyte specific reagent that can be used on real-time PCR platforms. The mix co |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DSQ ALERT 98144462 not registered Live/Pending |
ELITechGroup MDx LLC 2023-08-22 |