Neutral Density Densitometer Control for QuickScan

GUDID M52510310000

HELENA LABORATORIES CORPORATION

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

• Primary Device ID: M52510310000
• NIH Device Record Key: ff433b46-874e-47f0-975a-a3d930b337f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neutral Density Densitometer Control for QuickScan
• Version Model Number: 1031000
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M52510310000 [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: 5
• Public Version Date: 2022-10-10
• Device Publish Date: 2017-03-17

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