MHV Control Primers 4 3805

GUDID 00840487101414

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 RNA internal control reagent IVD

• Primary Device ID: 00840487101414
• NIH Device Record Key: 706bafcd-a497-4c50-9dc7-63aae4ccf9e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MHV Control Primers 4
• Version Model Number: 3805
• Catalog Number: 3805
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840487101414 [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

Devices Manufactured by LUMINEX CORPORATION

• 00840487101797 - MAGPIX® Drive Fluid PLUS (4PK): 2022-09-16 The MAGPIX Drive Fluid PLUS serves as the delivery medium that carries the sample to the optics component of the MAGPIX instrume
• 00840487101803 - xMAP® Sheath Fluid PLUS: 2022-09-16 Sheath Fluid PLUS is the delivery medium of the sample to the optics component.
• 00840487101780 - xMAP® Sheath Concentrate PLUS: 2021-03-08 A concentrated version of xMAP® Sheath Fluid PLUS, when diluted is is the delivery medium of the sample to the optics component
• 00840487101766 - VERIGENE® II System: 2019-12-25 The VERIGENE® II System is an in vitro diagnostic (IVD) platform that performs nucleic acid based tests in clinical laboratorie
• 00840487101773 - VERIGENE® II Module: 2019-12-25 The VERIGENE® II Module is a component of the VERGIENE® II System. When installed in the VERIGENE® II System it is capable o
• 00840487101445 - ARIES® MRSA Assay: 2019-10-16 The ARIES® MRSA Assay is an integrated real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for
• 00840487100059 - ARIES® C. difficile Assay: 2018-07-06 The ARIES® C. difficile Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the
• 00840487100073 - ARIES® Extraction Kit: 2018-07-06 The ARIES® Extraction Kit is intended to extract nucleic acid from human biological specimens and universal transport media (UT