IRISpec

Basic Information

• Brand Name: IRISpec
• Primary DI: 10837461002680
• Version / Model: CA/CB/CC URINE CHEMSITRY CONTROLS
• Catalog Number: 800-7702
• Company Name: BECKMAN COULTER IRELAND INC.
• Labeler DUNS: 985071975
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-07
• Public Version: 4
• Public Version Date: 2023-10-13
• Public Version Status: Update
• Public Device Record Key: 421b7ef5-844f-4ab7-a747-ef6caa42d2e9

Device Description

IRISPEC CA/CB/CC URINE CHEMISTRY CONTROLS

Device Characteristics

• Single Use: Yes
• 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: 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
JJW	Urinalysis Controls (Assayed And Unassayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
30219	Multiple urine analyte IVD, control	A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or semi-quantitative screening of urine for multiple analytes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10837461002680	GS1

Premarket Submissions

Submission Number	Supplement Number
K072640	000