OPTIGEN® Negative Control Reagent

Basic Information

• Brand Name: OPTIGEN® Negative Control Reagent
• Primary DI: 00813382010099
• Version / Model: 82062
• Catalog Number: 82062
• Company Name: Minaris Medical America, Inc.
• Labeler DUNS: 102113867
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2016-08-19
• Public Version: 5
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: f00fe926-c0e8-4b3a-a211-d7e7ff11592f

Device Description

OPTIGEN Negative Control

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• PM Exempt: No
• 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
DGC	IGE, ANTIGEN, ANTISERUM, CONTROL	Immunology	866.5510	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58947	Allergen-specific/total immunoglobulin E (IgE) antibody 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 immunoglobulin E (IgE) antibodies to one or multiple allergens and total immunoglobulin E (IgE total) antibodies in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813382010099	GS1
Unit of Use	00813382010310	GS1

Customer Contacts

• Phone: [phone] ext. 686
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K051677	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 10 Degrees Celsius