THC CAL DA2700

GUDID 05055273207842

The Randox Cannabinoid Calibrator Set is intended for use in the calibration of the 11-nor-Δ9-THC-9-COOH (Cannabinoid) assay.

RANDOX LABORATORIES LIMITED

Cannabinoid IVD, calibrator

• Primary Device ID: 05055273207842
• NIH Device Record Key: bd813bcf-a019-4eee-a402-8a75a7c3b343
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THC CAL
• Version Model Number: DA2700
• Catalog Number: DA2700
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273207842 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092269

FDA Product Code

• JIT: Calibrator, Secondary

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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