ImCap Rack

Basic Information

• Brand Name: ImCap Rack
• Primary DI: 05060169691117
• Version / Model: CQ-FULL
• Company Name: IMMUNODIAGNOSTIC SYSTEMS LIMITED
• Labeler DUNS: 494268600
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-04-01
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 554eab7d-7353-48cc-a12f-26eec991b654

Device Characteristics

• Single Use: No
• 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: 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
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15186	Test tube rack	A non-sterile device designed to hold test tubes in an upright and secured position. It is typically made of metal and/or plastic and consists of a base plate upon which it stands and second plate containing a mesh (grid of square slots) or round holes which is supported at a given height with spacers or diving walls. It is typically used in a clinical laboratory. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060169691117	GS1

Customer Contacts

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