iQ®200

Basic Information

• Brand Name: iQ®200
• Primary DI: 10837461002376
• Version / Model: iQ® Lamina™ Case of 2 x 7 L
• Catalog Number: 800-3236
• Company Name: BECKMAN COULTER IRELAND INC.
• Labeler DUNS: 985071975
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2016-09-07
• Public Version: 3
• Public Version Date: 2023-10-13
• Public Version Status: Update
• Public Device Record Key: e49febeb-c123-43e7-bcb3-fb9c5be2bc92

Device Description

iQ® Lamina™ Case of 2 x 7 L

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: 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
PPM	General Purpose Reagent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
59058	Wash/cleaning solution IVD, automated/semi-automated system	A concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10837461002376	GS1
Unit of Use	10837461000990	GS1