SPIFE Nexus Acid Hemoglobin Kit

GUDID M5255527340

HELENA LABORATORIES CORPORATION

Inherited haemoglobinopathy IVD, reagent

• Primary Device ID: M5255527340
• NIH Device Record Key: 116ef409-fd19-4b00-97a6-e6a65e70273e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPIFE Nexus Acid Hemoglobin Kit
• Version Model Number: 552734
• 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
• 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	M5255527340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992199

FDA Product Code

• JBD: SYSTEM, ANALYSIS, ELECTROPHORETIC HEMOGLOBIN

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: 2023-05-24
• Device Publish Date: 2023-05-16

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