MGB Alert® BKV Probe Mix ASR-48rxn 800421
GUDID 03661540951534
"MGB Alert® BK Virus Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from BK Virus. The mix consists of one probe at 1.5 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6- carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm."
ELITECH GROUP INC.
BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)| Primary Device ID | 03661540951534 |
| NIH Device Record Key | c3f00b7c-1c4b-4582-9d22-bd0b275597ac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MGB Alert® BKV Probe Mix ASR-48rxn |
| Version Model Number | 800421 |
| Catalog Number | 800421 |
| 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 | 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 | 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 |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03661540951534 [Primary] |
FDA Product Code
| MVU | Reagents, Specific, Analyte |
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 | 2020-09-16 |
| Device Publish Date | 2020-09-08 |
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 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.