Actalyke XL, (CSA/CE), W/ Flash Memory

Basic Information

• Brand Name: Actalyke XL, (CSA/CE), W/ Flash Memory
• Primary DI: M52557700040
• Version / Model: 5770004
• Company Name: HELENA LABORATORIES CORPORATION
• Labeler DUNS: 836287433
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-22
• Public Version: 4
• Public Version Date: 2023-09-11
• Public Version Status: Update
• Public Device Record Key: 1da00586-f32c-421a-a4e1-069904db4067

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JBP	ACTIVATED WHOLE BLOOD CLOTTING TIME	Hematology	864.7140	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56689	Coagulation analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of one or multiple coagulation components involved in haemostasis in a clinical specimen [e.g., performs tests such as prothrombin time (PT), partial thromboplastin time (PTT)]. Analyser design may incorporate spectrophotometry, turbidimetry, nephelometry, electrometry, electromagnetic and/or mechanical means of clot formation or end point detection.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M52557700040	HIBCC

Customer Contacts

• Phone: [phone] ext. 1600
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K020914	000