ProtoFluor Z (220V)

GUDID M52520060000

HELENA LABORATORIES CORPORATION

Fluorescent spectrophotometer IVD Fluorescent spectrophotometer IVD Fluorescent spectrophotometer IVD Fluorescent spectrophotometer IVD Fluorescent spectrophotometer IVD Fluorescent spectrophotometer IVD Fluorescent spectrophotometer IVD Fluorescent spectrophotometer IVD Fluorescent spectrophotometer IVD Fluorescent spectrophotometer IVD Fluorescent spectrophotometer IVD Fluorescent spectrophotometer IVD Fluorescent spectrophotometer IVD Fluorescent spectrophotometer IVD

• Primary Device ID: M52520060000
• NIH Device Record Key: 054aafdd-c83b-46ae-9070-66618b3fdf9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProtoFluor Z (220V)
• Version Model Number: 2006000
• Company DUNS: 836287433
• 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: 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	M52520060000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K893038

FDA Product Code

• JKJ: FLUOROMETRIC MEASUREMENT, PORPHYRINS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-09-16
• Device Publish Date: 2017-03-17

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