MHV DNA Amplification Control 3694

GUDID 00840487101100

Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

LUMINEX CORPORATION

Endogenous DNA internal control reagent IVD

• Primary Device ID: 00840487101100
• NIH Device Record Key: 0559a26b-5dee-4bda-ae88-3a52ce507651
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MHV DNA Amplification Control
• Version Model Number: 3694
• Catalog Number: 3694
• Company DUNS: 079686463
• Company Name: LUMINEX CORPORATION
• 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: false
• 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: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840487101100 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-12-16

On-Brand Devices [MHV DNA Amplification Control]

• 00840487101124: Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic var
• 00840487101117: Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic var
• 00840487101100: Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic var