ARK™ HS Benzodiazepine II Assay 5073-0001-01

GUDID 00812101030486

The ARK™ HS Benzodiazepine II Assay is intended for the qualitative and/or semiquantitative determination of benzodiazepines in human urine at cutoff concentrations of 100 ng/mL and 200 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting benzodiazepines in urine and is designated for professional use on automated clinical chemistry analyzers.

ARK DIAGNOSTICS INC

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• Primary Device ID: 00812101030486
• NIH Device Record Key: 9145665b-cc39-41b9-b9a3-3128eea88475
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARK™ HS Benzodiazepine II Assay
• Version Model Number: 5073-0001-01
• Catalog Number: 5073-0001-01
• Company DUNS: 164880598
• Company Name: ARK DIAGNOSTICS INC
• 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: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812101030486 [Primary]

FDA Product Code

• JXM: Enzyme Immunoassay, Benzodiazepine

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-08
• Device Publish Date: 2021-08-31

On-Brand Devices [ ARK™ HS Benzodiazepine II Assay]

• 00812101030493: The ARK™ HS Benzodiazepine II Assay is intended for the qualitative and/or semiquantitative d
• 00812101030486: The ARK™ HS Benzodiazepine II Assay is intended for the qualitative and/or semiquantitative d
• 00812101030479: The ARK™ HS Benzodiazepine II Assay is intended for the qualitative and/or semiquantitative d