MGB Alert® Internal Control Set IC2-B, 48 rxn 800430
GUDID 03661540951602
The MGB Alert Internal Control Set IC2-B 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 Internal Control Set IC2-B 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.
ELITECH GROUP INC.
Exogenous DNA internal control kit IVD| Primary Device ID | 03661540951602 |
| NIH Device Record Key | 12886a4d-2764-4b9c-afed-bd2d67d9cd1f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MGB Alert® Internal Control Set IC2-B, 48 rxn |
| Version Model Number | 800430 |
| Catalog Number | 800430 |
| Company DUNS | 079696864 |
| Company Name | ELITECH GROUP INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 |
Customer Support Contacts
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com | |
| Phone | 800-453-2725 |
| MDx@elitechgroup.com |
Operating and Storage Conditions
| 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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03661540951602 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K083430
FDA Product Code
| OLD | Internal Polymerase Chain Reaction Control, Not Assay Specific |
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 | 2020-09-23 |
| Device Publish Date | 2020-09-15 |
Devices Manufactured by ELITECH GROUP INC.
| 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 |
Trademark Results [MGB Alert]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MGB ALERT 78702861 3184945 Live/Registered |
ELITECHGROUP B.V. 2005-08-29 |
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