THC CONTROL 2 DA3128

GUDID 05055273207965

The Randox Cannabinoid Control - Level 2 is intended for use in the Quality Control of the 11-nor-Δ9-THC-9-COOH (Cannabinoid) assay. The Cannabinoid C

RANDOX LABORATORIES LIMITED

Cannabinoid IVD, control

• Primary Device ID: 05055273207965
• NIH Device Record Key: 4cc49efb-c888-45f3-b7f3-7da1011aa82f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THC CONTROL 2
• Version Model Number: DA3128
• Catalog Number: DA3128
• 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
• 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

• Special Storage Condition, Specify: Between 0 and 0 *Once opened the Cannabinoid Quality Control materials are stable for 28 days at +2 to +8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the Cannabinoid Quality Control materials are stable for 28 days at +2 to +8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the Cannabinoid Quality Control materials are stable for 28 days at +2 to +8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the Cannabinoid Quality Control materials are stable for 28 days at +2 to +8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the Cannabinoid Quality Control materials are stable for 28 days at +2 to +8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the Cannabinoid Quality Control materials are stable for 28 days at +2 to +8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the Cannabinoid Quality Control materials are stable for 28 days at +2 to +8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the Cannabinoid Quality Control materials are stable for 28 days at +2 to +8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the Cannabinoid Quality Control materials are stable for 28 days at +2 to +8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the Cannabinoid Quality Control materials are stable for 28 days at +2 to +8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the Cannabinoid Quality Control materials are stable for 28 days at +2 to +8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the Cannabinoid Quality Control materials are stable for 28 days at +2 to +8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the Cannabinoid Quality Control materials are stable for 28 days at +2 to +8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the Cannabinoid Quality Control materials are stable for 28 days at +2 to +8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the Cannabinoid Quality Control materials are stable for 28 days at +2 to +8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the Cannabinoid Quality Control materials are stable for 28 days at +2 to +8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the Cannabinoid Quality Control materials are stable for 28 days at +2 to +8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the Cannabinoid Quality Control materials are stable for 28 days at +2 to +8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the Cannabinoid Quality Control materials are stable for 28 days at +2 to +8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the Cannabinoid Quality Control materials are stable for 28 days at +2 to +8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the Cannabinoid Quality Control materials are stable for 28 days at +2 to +8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the Cannabinoid Quality Control materials are stable for 28 days at +2 to +8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the Cannabinoid Quality Control materials are stable for 28 days at +2 to +8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the Cannabinoid Quality Control materials are stable for 28 days at +2 to +8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the Cannabinoid Quality Control materials are stable for 28 days at +2 to +8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the Cannabinoid Quality Control materials are stable for 28 days at +2 to +8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273207965 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092269

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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: 2016-09-24

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