QuickProfile™ Drugs of Abuse Panel 4 Test 07RD7063-03

GUDID M90107RD7063031

Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / MTD / OPI

LUMIQUICK DIAGNOSTICS, INC.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: M90107RD7063031
• NIH Device Record Key: 066d46a6-2db0-4b03-bd12-29be3d7d1bae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuickProfile™ Drugs of Abuse Panel 4 Test
• Version Model Number: 07RD7063-03
• Catalog Number: 07RD7063-03
• Company DUNS: 790175165
• Company Name: LUMIQUICK 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: false
• 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: 1-408-855-0061
• Email: udi@lumiquick.com
• Phone: 1-408-855-0061
• Email: udi@lumiquick.com
• Phone: 1-408-855-0061
• Email: udi@lumiquick.com
• Phone: 1-408-855-0061
• Email: udi@lumiquick.com
• Phone: 1-408-855-0061
• Email: udi@lumiquick.com
• Phone: 1-408-855-0061
• Email: udi@lumiquick.com
• Phone: 1-408-855-0061
• Email: udi@lumiquick.com
• Phone: 1-408-855-0061
• Email: udi@lumiquick.com
• Phone: 1-408-855-0061
• Email: udi@lumiquick.com
• Phone: 1-408-855-0061
• Email: udi@lumiquick.com
• Phone: 1-408-855-0061
• Email: udi@lumiquick.com
• Phone: 1-408-855-0061
• Email: udi@lumiquick.com
• Phone: 1-408-855-0061
• Email: udi@lumiquick.com
• Phone: 1-408-855-0061
• Email: udi@lumiquick.com
• Phone: 1-408-855-0061
• Email: udi@lumiquick.com
• Phone: 1-408-855-0061
• Email: udi@lumiquick.com
• Phone: 1-408-855-0061
• Email: udi@lumiquick.com

Device Dimensions

• Length: 75 Millimeter
• Length: 75 Millimeter
• Length: 75 Millimeter
• Length: 75 Millimeter
• Length: 75 Millimeter
• Length: 75 Millimeter
• Length: 75 Millimeter
• Length: 75 Millimeter
• Length: 75 Millimeter
• Length: 75 Millimeter
• Length: 75 Millimeter
• Length: 75 Millimeter
• Length: 75 Millimeter
• Length: 75 Millimeter
• Length: 75 Millimeter
• Length: 75 Millimeter
• Length: 75 Millimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M90107RD7063030 [Primary]
HIBCC	M90107RD7063031 [Package]; Contains: M90107RD7063030; Package: PACK [25 Units]; In Commercial Distribution

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: 3
• Public Version Date: 2021-05-24
• Device Publish Date: 2017-11-15

On-Brand Devices [QuickProfile™ Drugs of Abuse Panel 4 Test]

• M90107RD7063280: Immunoassay for the detection of the following drug substance(s) in human urine: BUP / MTD / OPI
• M90107RD7063031: Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / MTD
• M90107RD7063021: Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / O
• M90107RD7063011: Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / OPI