GLUC-PAP GL366

GUDID 05055273203233

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

RANDOX LABORATORIES LIMITED

Glucose IVD, reagent

• Primary Device ID: 05055273203233
• NIH Device Record Key: 5178e9e7-6c04-4c6f-b223-be8bfa30da23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GLUC-PAP
• Version Model Number: GL366
• Catalog Number: GL366
• 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
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The working reagent is stable for 3 months at +2 to +8°C or 5 days at +15 to +25°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The working reagent is stable for 3 months at +2 to +8°C or 5 days at +15 to +25°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The working reagent is stable for 3 months at +2 to +8°C or 5 days at +15 to +25°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The working reagent is stable for 3 months at +2 to +8°C or 5 days at +15 to +25°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The working reagent is stable for 3 months at +2 to +8°C or 5 days at +15 to +25°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The working reagent is stable for 3 months at +2 to +8°C or 5 days at +15 to +25°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The working reagent is stable for 3 months at +2 to +8°C or 5 days at +15 to +25°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The working reagent is stable for 3 months at +2 to +8°C or 5 days at +15 to +25°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The working reagent is stable for 3 months at +2 to +8°C or 5 days at +15 to +25°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The working reagent is stable for 3 months at +2 to +8°C or 5 days at +15 to +25°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The working reagent is stable for 3 months at +2 to +8°C or 5 days at +15 to +25°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The working reagent is stable for 3 months at +2 to +8°C or 5 days at +15 to +25°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The working reagent is stable for 3 months at +2 to +8°C or 5 days at +15 to +25°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The working reagent is stable for 3 months at +2 to +8°C or 5 days at +15 to +25°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The working reagent is stable for 3 months at +2 to +8°C or 5 days at +15 to +25°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The working reagent is stable for 3 months at +2 to +8°C or 5 days at +15 to +25°C.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273203233 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003346

FDA Product Code

• CGA: Glucose Oxidase, 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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-16

On-Brand Devices [GLUC-PAP]

• 05055273203318: The product is intended for the quantitative in vitro determination of Glucose in serum, plasma
• 05055273203271: A glucose test system is a device intended for the quantitative in vitro determination of Glucos
• 05055273203240: A glucose test system is a device intended for the quantitative in vitro determination of Glucos
• 05055273203233: A glucose test system is a device intended for the quantitative in vitro determination of Glucos
• 05055273203226: A glucose test system is a device intended for the quantitative in vitro determination of Glucos
• 05055273203202: A glucose test system is a device intended for the quantitative in vitro determination of Glucos
• 05055273203196: A glucose test system is a device intended for the quantitative in vitro determination of Glucos
• 05055273203165: A glucose test system is a device intended for the quantitative in vitro determination of Glucos