BENZ DA4009

GUDID 05055273208023

The Benzodiazepine assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of Benzodiazepines in human urine

RANDOX LABORATORIES LIMITED

Benzodiazepine group IVD, reagent Benzodiazepine group IVD, reagent Benzodiazepine group IVD, reagent Benzodiazepine group IVD, reagent Benzodiazepine group IVD, reagent Benzodiazepine group IVD, reagent Benzodiazepine group IVD, reagent Benzodiazepine group IVD, reagent Benzodiazepine group IVD, reagent Benzodiazepine group IVD, reagent Benzodiazepine group IVD, reagent Benzodiazepine group IVD, reagent Benzodiazepine group IVD, reagent Benzodiazepine group IVD, reagent Benzodiazepine group IVD, reagent Benzodiazepine group IVD, reagent

• Primary Device ID: 05055273208023
• NIH Device Record Key: 655cad0a-d4f7-4a9a-9f23-0bbe3e751802
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BENZ
• Version Model Number: DA4009
• Catalog Number: DA4009
• 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	05055273208023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092274

FDA Product Code

• JXM: Enzyme Immunoassay, Benzodiazepine

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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