Detector Lex RA

Basic Information

• Brand Name: Detector Lex RA
• Primary DI: 10722355001477
• Version / Model: RA-100U
• Company Name: IMMUNOSTICS COMPANY, INC
• Labeler DUNS: 119214195
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 68220fec-c5c8-4e06-8ba8-a67eff7db269

Device Description

A rapid undiluted latex slide test for the detection of rheumatoid factors

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• 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
DHR	SYSTEM, TEST, RHEUMATOID FACTOR	Immunology	866.5775	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55112	Rheumatoid factor IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of rheumatoid factor immunoglobulins in a clinical specimen, using an agglutination method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10722355001477	GS1
Unit of Use	80722355001476	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K926569	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not freeze
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius