SPIFE 4000, Windows 7 (220V)

GUDID M52516210030

HELENA LABORATORIES CORPORATION

Electrophoresis analyser IVD, automated

• Primary Device ID: M52516210030
• NIH Device Record Key: ce74f8bb-d062-4393-acff-cc3a357489cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPIFE 4000, Windows 7 (220V)
• Version Model Number: 1621003
• 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
• 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	M52516210030 [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: 2021-04-21
• Device Publish Date: 2017-03-17

Devices Manufactured by HELENA LABORATORIES CORPORATION

• M5255527370 - SPIFE Nexus IFE-6 Antisera Kit: 2024-10-07
• M5255527440 - SPIFE Nexus IFE-9/15 Antisera Kit: 2024-10-07
• M52594190 - IFE IgD Antiserum: 2024-10-07
• M52594200 - IFE IgE Antiserum: 2024-10-07
• M52594220 - IFE Free Kappa Light Chain Antiserum: 2024-10-07
• M52518360 - V8 Urine Preparation Buffer: 2023-09-18
• M5255526930 - SPIFE Nexus Split Beta SPE - 80, 100 Gel Kit: 2023-09-18
• M52510680010 - SPIFE Touch, CSA 2015 (120V): 2023-09-11