3-Reagent Homocysteine Assay for SYNCHRON UniCel FHYB100/B08175

GUDID 05055845400084

The 3-Reagent Homocysteine Assay for SYNCHRON UniCel DxC System is intended for in vitro quantitative determination of total homocysteine in human ser

AXIS-SHIELD DIAGNOSTICS LIMITED

Homocysteine IVD, reagent

• Primary Device ID: 05055845400084
• NIH Device Record Key: 1bde5089-8078-4b71-ac31-a1fd040ef599
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3-Reagent Homocysteine Assay for SYNCHRON UniCel
• Version Model Number: FHYB100/B08175
• Catalog Number: FHYB100/B08175
• Company DUNS: 229062427
• Company Name: AXIS-SHIELD DIAGNOSTICS LIMITED
• 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: true
• Device Combination Product: false
• Single Use: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +441382422000
• Email: MDL-AXD-Product-Support@alere.

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055845400084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112790

FDA Product Code

• LPS: Urinary Homocystine (Nonquantitative) Test System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-01

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