MHV Control Primers 3

Basic Information

• Brand Name: MHV Control Primers 3
• Primary DI: 00840487101216
• Version / Model: 3804-22
• Catalog Number: 3804-22
• Company Name: LUMINEX CORPORATION
• Labeler DUNS: 079686463
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-16
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 52302bc9-e57a-49d2-a9f6-e11b3552a652

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OLD	Internal polymerase chain reaction control, not assay specific	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62401	Endogenous RNA internal control reagent IVD	A substance or reactant intended to be used as an endogenous component in a molecular assay to verify the extraction and/or amplification process applied to target ribonucleic acid (RNA), and/or verify the absence of inhibiting substances, in a clinical specimen.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840487101216	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -30 – -15 Degrees Celsius