SPIFE Nexus IFE-6 Antisera Kit

GUDID M5255527030

HELENA LABORATORIES CORPORATION

Protein electrophoresis IVD, kit, electrophoresis

• Primary Device ID: M5255527030
• NIH Device Record Key: 3ed37b46-976f-493c-9977-d066af5ed434
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPIFE Nexus IFE-6 Antisera Kit
• Version Model Number: 552703
• Company DUNS: 079396131
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M5255527030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973040

FDA Product Code

• CFF: Immunoelectrophoretic, Immunoglobulins, (G, A, M)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-02
• Device Publish Date: 2022-05-25

On-Brand Devices [SPIFE Nexus IFE-6 Antisera Kit]

• M5255527030: 552703
• M5255527370: 552737