HemosIL AcuStar D-Dimer Controls

Basic Information

• Brand Name: HemosIL AcuStar D-Dimer Controls
• Primary DI: 08426950498032
• Version / Model: 0009802100
• Catalog Number: 0009802100
• Company Name: INSTRUMENTATION LABORATORY COMPANY
• Labeler DUNS: 557223252
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 6
• Public Version Date: 2021-07-13
• Public Version Status: Update
• Public Device Record Key: 12a36a04-0afd-4e80-881d-4596f7657a00

Device Description

HemosIL AcuStar D-Dimer Controls

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
GGN	PLASMA, COAGULATION CONTROL	Hematology	864.5425	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47347	D-dimer IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of D-dimer protein in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08426950498032	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K083518	000

Storage Conditions

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