MDMA DA4014

GUDID 05055273208078

The MDMA assay is an in vitro diagnostic reagent. For the qualitative and semi-quantitative analysis of MDMA in human urine.

RANDOX LABORATORIES LIMITED

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• Primary Device ID: 05055273208078
• NIH Device Record Key: 0e7731bf-284b-4315-a6b3-5fa1b6fa0635
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MDMA
• Version Model Number: DA4014
• Catalog Number: DA4014
• 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 *Once opened the reagent is stable on board the analyser for 28 days at approximately +10°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the reagent is stable on board the analyser for 28 days at approximately +10°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the reagent is stable on board the analyser for 28 days at approximately +10°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the reagent is stable on board the analyser for 28 days at approximately +10°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the reagent is stable on board the analyser for 28 days at approximately +10°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the reagent is stable on board the analyser for 28 days at approximately +10°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the reagent is stable on board the analyser for 28 days at approximately +10°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the reagent is stable on board the analyser for 28 days at approximately +10°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the reagent is stable on board the analyser for 28 days at approximately +10°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the reagent is stable on board the analyser for 28 days at approximately +10°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the reagent is stable on board the analyser for 28 days at approximately +10°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the reagent is stable on board the analyser for 28 days at approximately +10°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the reagent is stable on board the analyser for 28 days at approximately +10°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the reagent is stable on board the analyser for 28 days at approximately +10°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened the reagent is stable on board the analyser for 28 days at approximately +10°C.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273208078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092275

FDA Product Code

• DKZ: Enzyme Immunoassay, Amphetamine

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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