QuickProfile™ Drugs of Abuse Panel 2 Test 07RD7061-04A

GUDID M90107RD706104A1

Immunoassay for the detection of the following drug substance(s) in human urine: BZD / OPI-2000

LUMIQUICK DIAGNOSTICS, INC.

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• Primary Device ID: M90107RD706104A1
• NIH Device Record Key: 14f07338-262a-4bed-a558-38475857c501
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuickProfile™ Drugs of Abuse Panel 2 Test
• Version Model Number: 07RD7061-04A
• Catalog Number: 07RD7061-04A
• 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	M90107RD706104A0 [Primary]
HIBCC	M90107RD706104A1 [Package]; Contains: M90107RD706104A0; 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 2 Test]

• M90107RD706104A1: Immunoassay for the detection of the following drug substance(s) in human urine: BZD / OPI-2000
• M90107RD7061031: Immunoassay for the detection of the following drug substance(s) in human urine: MAMP / THC
• M90107RD706102A1: Immunoassay for the detection of the following drug substance(s) in human urine: M-AMP / OPI-200
• M90107RD7061011: Immunoassay for the detection of the following drug substance(s) in human urine: COC / THC