AccuPlex SARS-CoV-2 Molecular Controls Kit – Full Genome

Basic Information

• Brand Name: AccuPlex SARS-CoV-2 Molecular Controls Kit – Full Genome
• Primary DI: 00816784020987
• Version / Model: 0505-0159
• Company Name: Lgc Clinical Diagnostics, Inc.
• Labeler DUNS: 106267123
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-21
• Public Version: 2
• Public Version Date: 2022-03-28
• Public Version Status: Update
• Public Device Record Key: 5b4a77de-0e1b-496a-b7d7-545d6830b5ae

Device Description

AccuPlex SARS-CoV-2 Molecular Controls Kit – Full Genome (Positive and Negative member-5 X 1.5 ml)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
JJX	Single (Specified) Analyte Controls (Assayed And 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	00816784020987	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius