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

• 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

Devices Manufactured by RANDOX LABORATORIES LIMITED

• 05055273220018 - PlaySafe™: 2024-10-09 The PlaySafe kit is intended for use in the collection of a urine sample for laboratory analysis of nine sexually transmitted in
• 05055273216752 - Evidence MultiSTAT DOA Urine MultiPlex: 2024-09-24 The Evidence MultiSTAT DOA Urine MultiPlex is intended for use with the Evidence MultiSTAT. The Evidence MultiSTAT is an analyze
• 05055273214970 - Evidence MultiSTAT: 2024-09-23 The Evidence MultiSTAT is a benchtop, fully automated, immunoassay analyser that has been designed and developed to be operated
• 05055273219951 - ESSENTIAL PACKAGE SAMPLE COLLECTION KIT (USA): 2024-02-07 The Blood Sample Collection Kit is intended for use in the collection and transport of a blood sample, taken by a trained phlebo
• 05055273219968 - EXTENDED PACKAGE SAMPLE COLLECTION KIT (USA): 2024-02-07 The Blood Sample Collection Kit is intended for use in the collection and transport of a blood sample, taken by a trained phlebo
• 05055273219999 - EXTENDED PACKAGE SAMPLE COLLECTION KIT (USA U60): 2024-02-07 The Blood Sample Collection Kit is intended for use in the collection and transport of a blood sample, taken by a trained phlebo
• 05055273218480 - BNP CONTROLS FOR BECKMAN (BNP CONTROL): 2023-12-29 The BNP Controls for Beckman (CQ10520) are intended for use with in vitro diagnostic assays for the quantitative determination o
• 05055273218497 - BNP CONTROLS FOR ABBOTT (BNP CONTROL): 2023-12-29 The BNP Controls for Abbott (CQ10521) are intended for use with in vitro diagnostic assays for the quantitative determination of