MGB Alert MS2 Internal Control RNA Template (480uL volume)

GUDID 03661540952425

The MGB Alert Internal Control MS2 RNA Template consists of an RNA bacteriophage intended for use as an internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The MS2 Internal Control can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The internal control is not intended to monitor other real-time PCR processes.

Elitechgroup Mdx LLC

Nucleic acid amplification primer IVD Nucleic acid amplification primer IVD Nucleic acid amplification primer IVD Nucleic acid amplification primer IVD Nucleic acid amplification primer IVD Nucleic acid amplification primer IVD Nucleic acid amplification primer IVD Nucleic acid amplification primer IVD Nucleic acid amplification primer IVD Nucleic acid amplification primer IVD Nucleic acid amplification primer IVD Nucleic acid amplification primer IVD Nucleic acid amplification primer IVD Nucleic acid amplification primer IVD

• Primary Device ID: 03661540952425
• NIH Device Record Key: 4a8160cc-6923-4523-a8a1-0b5d7e9d653a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MGB Alert MS2 Internal Control RNA Template (480uL volume)
• Version Model Number: M800740
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661540952425 [Primary]

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: 2022-09-07
• Device Publish Date: 2022-08-30

Devices Manufactured by Elitechgroup Mdx LLC

• 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: 2023-09-29 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