QuickScan 2000 Software, Version 2.02

GUDID M52516780000

HELENA LABORATORIES CORPORATION

Densitometry analyser IVD Densitometry analyser IVD Densitometry analyser IVD Densitometry analyser IVD Densitometry analyser IVD Densitometry analyser IVD Densitometry analyser IVD Densitometry analyser IVD Densitometry analyser IVD Densitometry analyser IVD Densitometry analyser IVD Densitometry analyser IVD Densitometry analyser IVD Densitometry analyser IVD

• Primary Device ID: M52516780000
• NIH Device Record Key: 906e0a4f-b43f-410e-aeb7-4dfde6f2947b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuickScan 2000 Software, Version 2.02
• Version Model Number: 1678000
• Company DUNS: 836287433
• Company Name: HELENA LABORATORIES CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M52516780000 [Primary]

FDA Product Code

• JQJ: DENSITOMETERIC, PROTEIN FRACTIONATION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-09-16
• Device Publish Date: 2017-03-17

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