Scale Set Solutions for AggRAM & PACKS-4 Platelet Assays

GUDID M52514790

HELENA LABORATORIES CORPORATION

Optical instrument performance standard calibrator/control IVD, single-use

• Primary Device ID: M52514790
• NIH Device Record Key: dd2b01b0-68a5-41ad-aeba-2888926590a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scale Set Solutions for AggRAM & PACKS-4 Platelet Assays
• Version Model Number: 1479
• Company DUNS: 079396131
• Company Name: HELENA LABORATORIES CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)231-5663
• Email: helena@helena.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M52514790 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K924915

FDA Product Code

• JJY: Multi-analyte controls, all kinds (assayed)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2022-10-10
• Device Publish Date: 2017-03-17

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