SPIFE 3000, "CE 2011" (230V)

GUDID M52510890020

HELENA LABORATORIES CORPORATION

Electrophoresis analyser IVD Electrophoresis analyser IVD Electrophoresis analyser IVD Electrophoresis analyser IVD Electrophoresis analyser IVD Electrophoresis analyser IVD Electrophoresis analyser IVD Electrophoresis analyser IVD Electrophoresis analyser IVD Electrophoresis analyser IVD Electrophoresis analyser IVD Electrophoresis analyser IVD Electrophoresis analyser IVD Electrophoresis analyser IVD Electrophoresis analyser IVD Electrophoresis analyser IVD Electrophoresis analyser IVD Electrophoresis analyser IVD

• Primary Device ID: M52510890020
• NIH Device Record Key: b5f0e368-748c-4de0-ae55-f537fd16b4c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPIFE 3000, "CE 2011" (230V)
• Version Model Number: 1089002
• 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
• 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	M52510890020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972274

FDA Product Code

• CEF: ELECTROPHORETIC, 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: 4
• Public Version Date: 2023-09-11
• Device Publish Date: 2017-03-17

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• M52510690000 - SPIFE Touch (230V): 2023-09-11
• M52510880010 - SPIFE 3000 w/ New Pump & Valve (110V): 2023-09-11
• M52510880020 - SPIFE 3000, "CE 2011" (120V): 2023-09-11
• M52510890010 - SPIFE 3000 w/ New Pump & Valve (220V): 2023-09-11
• M52510890020 - SPIFE 3000, "CE 2011" (230V): 2023-09-11
• M52510890020 - SPIFE 3000, "CE 2011" (230V): 2023-09-11