Primary Device ID | 03661540952371 |
NIH Device Record Key | 53e42fca-b0ae-4a97-b4a5-415f1c1cfef1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MGB Alert IC1 Internal Control Template (35uL volume) |
Version Model Number | M800735 |
Company DUNS | 079696864 |
Company Name | ELITECH GROUP INC. |
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 |
Phone | 425.482.5555 |
mdx@elitechgroup.com | |
Phone | 425.482.5555 |
mdx@elitechgroup.com | |
Phone | 425.482.5555 |
mdx@elitechgroup.com | |
Phone | 425.482.5555 |
mdx@elitechgroup.com | |
Phone | 425.482.5555 |
mdx@elitechgroup.com | |
Phone | 425.482.5555 |
mdx@elitechgroup.com | |
Phone | 425.482.5555 |
mdx@elitechgroup.com | |
Phone | 425.482.5555 |
mdx@elitechgroup.com | |
Phone | 425.482.5555 |
mdx@elitechgroup.com | |
Phone | 425.482.5555 |
mdx@elitechgroup.com | |
Phone | 425.482.5555 |
mdx@elitechgroup.com | |
Phone | 425.482.5555 |
mdx@elitechgroup.com | |
Phone | 425.482.5555 |
mdx@elitechgroup.com | |
Phone | 425.482.5555 |
mdx@elitechgroup.com | |
Phone | 425.482.5555 |
mdx@elitechgroup.com | |
Phone | 425.482.5555 |
mdx@elitechgroup.com | |
Phone | 425.482.5555 |
mdx@elitechgroup.com | |
Phone | 425.482.5555 |
mdx@elitechgroup.com | |
Phone | 425.482.5555 |
mdx@elitechgroup.com | |
Phone | 425.482.5555 |
mdx@elitechgroup.com | |
Phone | 425.482.5555 |
mdx@elitechgroup.com |
Special Storage Condition, Specify | Between 0 and 0 *Less or equal to -10C Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Less or equal to -10C Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Less or equal to -10C Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Less or equal to -10C Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Less or equal to -10C Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Less or equal to -10C Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Less or equal to -10C Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Less or equal to -10C Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Less or equal to -10C Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Less or equal to -10C Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Less or equal to -10C Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Less or equal to -10C Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Less or equal to -10C Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Less or equal to -10C Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Less or equal to -10C Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Less or equal to -10C Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Less or equal to -10C Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Less or equal to -10C Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Less or equal to -10C Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Less or equal to -10C Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Less or equal to -10C Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 03661540952371 [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 | 2022-07-13 |
Device Publish Date | 2022-07-05 |
03661540952371 - MGB Alert IC1 Internal Control Template (35uL volume) | 2022-07-13The MGB Alert Internal Control Set IC1 consists of reagents intended for use as an un-assayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC1 can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes. |
03661540952371 - MGB Alert IC1 Internal Control Template (35uL volume) | 2022-07-13 The MGB Alert Internal Control Set IC1 consists of reagents intended for use as an un-assayed internal extraction and amplificat |
03661540952173 - MGB Alert® BKV Primer Mix ASR - 480 Reactions QTY 100 | 2022-04-12 MGB Alert® BK Virus Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences |
03661540952180 - MGB Alert® BKV Probe Mix ASR - 480 Reactions QTY-100 | 2022-04-12 MGB Alert® BK Virus Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designe |
03661540952197 - MGB Alert® CMV 3.0 Primer Mix ASR - 480 Reactions QTY-25 | 2022-04-12 MGB Alert® CMV 3.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences f |
03661540952203 - MGB Alert® CMV 3.0 Primer Mix ASR - 480 Reactions QTY-100 | 2022-04-12 MGB Alert® CMV 3.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences f |
03661540952210 - MGB Alert® CMV 3.0 Probe Mix ASR - 480 Reactions QTY-25 | 2022-04-12 MGB Alert® CMV 3.0 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed |
03661540952227 - MGB Alert® CMV 3.0 Probe Mix ASR - 480 Reactions QTY-100 | 2022-04-12 MGB Alert® CMV 3.0 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed |
03661540952258 - MGB Alert Internal Control Set IC2-B, 480 rxn QTY-25 | 2022-04-12 The MGB Alert Internal Control Set IC2-B consists of reagents intended for use as an un-assayed internal extraction and amplific |