GLUC-HK GL3816

GUDID 05055273203257

A Glucose test system is a device intended for the quantitative in vitro determination of glucose concentration in serum, lithium plasma and urine

RANDOX LABORATORIES LIMITED

Glucose IVD, reagent

• Primary Device ID: 05055273203257
• NIH Device Record Key: 7f8d8665-5f40-4a5b-85d1-8aaef2691001
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GLUC-HK
• Version Model Number: GL3816
• Catalog Number: GL3816
• Company DUNS: 227530649
• Company Name: RANDOX LABORATORIES 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: 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: +442894451070
• Email: technical.services@randox.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273203257 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953210

FDA Product Code

• CFR: Hexokinase, Glucose

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: 2016-09-16

On-Brand Devices [GLUC-HK]

• 05055273208764: The product is intended for the quantitative in vitro determination of Glucose in serum or urine
• 05055273203325: The product is intended for the quantitative in vitro determination of Glucose in serum, plasma
• 05055273203264: A Glucose test system is a device intended for the quantitative in vitro determination of glucos
• 05055273203257: A Glucose test system is a device intended for the quantitative in vitro determination of glucos
• 05055273203219: A Glucose test system is a device intended for the quantitative in vitro determination of glucos
• 05055273203189: A Glucose test system is a device intended for the quantitative in vitro determination of glucos