Coamatic LR Antithrombin

Basic Information

• Brand Name: Coamatic LR Antithrombin
• Primary DI: 08426950088936
• Version / Model: 82 2957 63
• Catalog Number: 82 2957 63
• Company Name: INSTRUMENTATION LABORATORY COMPANY
• Labeler DUNS: 557223252
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 7
• Public Version Date: 2021-07-13
• Public Version Status: Update
• Public Device Record Key: 9853d384-4626-40d9-b1bf-65b18f914663
• Distribution End Date: 2020-02-29

Device Description

Coamatic LR Antithrombin

Device Characteristics

• Single Use: No
• 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
JBQ	ANTITHROMBIN III QUANTITATION	Hematology	864.7060	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56155	Antithrombin III (ATIII) IVD, kit, chromogenic	A collection of reagents and other associated materials intended to be used for the quantitative measurement of antithrombin III (ATIII) in a clinical specimen, using a chromogenic method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08426950088936	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Unopened reagents and calibrator are stable until the expiration date shown on the vial when stored at 2-8°C.
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius