Helix Elite™ Molecular Standards: Synthetic Standard

Basic Information

• Brand Name: Helix Elite™ Molecular Standards: Synthetic Standard
• Primary DI: 10845357043631
• Version / Model: HE0062-DN
• Catalog Number: HE0062-DN
• Company Name: MICROBIOLOGICS INC.
• Labeler DUNS: 060467826
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-17
• Public Version: 1
• Public Version Date: 2020-12-25
• Public Version Status: New
• Public Device Record Key: 6e259fd2-c5e2-41e9-8e8a-669a165c4456

Device Description

Helix Elite™ Molecular Standards SARS-CoV-2 Process Control (Pellet)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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
OHQ	Multi-analyte controls unassayed	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64748	SARS-CoV-2 nucleic acid IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent for COVID-19, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10845357043631	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius