MHV DNA Sample Processing Control 3710-21

GUDID 00840487101094

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 Endogenous DNA internal control reagent IVD Endogenous DNA internal control reagent IVD Endogenous DNA internal control reagent IVD Endogenous DNA internal control reagent IVD Endogenous DNA internal control reagent IVD Endogenous DNA internal control reagent IVD Endogenous DNA internal control reagent IVD Endogenous DNA internal control reagent IVD Endogenous DNA internal control reagent IVD Endogenous DNA internal control reagent IVD Endogenous DNA internal control reagent IVD Endogenous DNA internal control reagent IVD Endogenous DNA internal control reagent IVD Endogenous DNA internal control reagent IVD Endogenous DNA internal control reagent IVD Endogenous DNA/RNA internal control reagent IVD Endogenous DNA/RNA internal control reagent IVD Endogenous DNA/RNA internal control reagent IVD Endogenous DNA/RNA internal control reagent IVD Endogenous DNA/RNA internal control reagent IVD Endogenous DNA/RNA internal control reagent IVD Endogenous DNA/RNA internal control reagent IVD Endogenous DNA/RNA internal control IVD, reagent Endogenous DNA/RNA internal control IVD, reagent Endogenous DNA/RNA internal control IVD, reagent Endogenous DNA/RNA internal control IVD, reagent Endogenous DNA/RNA internal control IVD, reagent Endogenous DNA/RNA internal control IVD, reagent Endogenous DNA/RNA internal control IVD, reagent Endogenous DNA/RNA internal control IVD, reagent Endogenous DNA/RNA internal control IVD, reagent Endogenous DNA/RNA internal control IVD, reagent Endogenous DNA/RNA internal control IVD, reagent Endogenous DNA/RNA internal control IVD, reagent Endogenous DNA/RNA internal control IVD, reagent Endogenous DNA/RNA internal control IVD, reagent

• Primary Device ID: 00840487101094
• NIH Device Record Key: d9a34b96-eec9-4b7f-9628-4734fa365efe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MHV DNA Sample Processing Control
• Version Model Number: 3710-21
• Catalog Number: 3710-21
• 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
• 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
• 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	00840487101094 [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 Sample Processing Control]

• 00840487101094: Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic var
• 00840487101087: Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic var
• 00840487101070: Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic var
• 00840487101063: Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic var
• 00840487101056: Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic var
• 00840487101049: Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic var