DOA 1 PANEL TEST 07RD7060-03

GUDID 00817830020678

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

RAPID DIAGNOSTICS INC

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

• Primary Device ID: 00817830020678
• NIH Device Record Key: 857414fa-6d14-4bea-8367-db676e5fac69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DOA 1 PANEL TEST
• Version Model Number: 07RD7060-03
• Catalog Number: 07RD7060-03
• Company DUNS: 008028248
• Company Name: RAPID 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(800)854-0530
• Email: custserv@mpbio.com
• Phone: +1(800)854-0530
• Email: custserv@mpbio.com
• Phone: +1(800)854-0530
• Email: custserv@mpbio.com
• Phone: +1(800)854-0530
• Email: custserv@mpbio.com
• Phone: +1(800)854-0530
• Email: custserv@mpbio.com
• Phone: +1(800)854-0530
• Email: custserv@mpbio.com
• Phone: +1(800)854-0530
• Email: custserv@mpbio.com
• Phone: +1(800)854-0530
• Email: custserv@mpbio.com
• Phone: +1(800)854-0530
• Email: custserv@mpbio.com
• Phone: +1(800)854-0530
• Email: custserv@mpbio.com
• Phone: +1(800)854-0530
• Email: custserv@mpbio.com
• Phone: +1(800)854-0530
• Email: custserv@mpbio.com
• Phone: +1(800)854-0530
• Email: custserv@mpbio.com
• Phone: +1(800)854-0530
• Email: custserv@mpbio.com
• Phone: +1(800)854-0530
• Email: custserv@mpbio.com
• Phone: +1(800)854-0530
• Email: custserv@mpbio.com
• Phone: +1(800)854-0530
• Email: custserv@mpbio.com
• Phone: +1(800)854-0530
• Email: custserv@mpbio.com
• Phone: +1(800)854-0530
• Email: custserv@mpbio.com
• Phone: +1(800)854-0530
• Email: custserv@mpbio.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
• Length: 75 Millimeter
• Length: 75 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817830020678 [Primary]

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: 2016-10-20

On-Brand Devices [DOA 1 PANEL TEST]

• 00817830020760: Immunoassay for the detection of the following drug substance(s) in human urine: BUP
• 00817830020753: Immunoassay for the detection of the following drug substance(s) in human urine: THC
• 00817830020746: Immunoassay for the detection of the following drug substance(s) in human urine: PCP
• 00817830020739: Immunoassay for the detection of the following drug substance(s) in human urine: OXY
• 00817830020722: Immunoassay for the detection of the following drug substance(s) in human urine: OPI-II
• 00817830020715: Immunoassay for the detection of the following drug substance(s) in human urine: OPI
• 00817830020708: Immunoassay for the detection of the following drug substance(s) in human urine: MTD
• 00817830020692: Immunoassay for the detection of the following drug substance(s) in human urine: M-AMP
• 00817830020685: Immunoassay for the detection of the following drug substance(s) in human urine: COC
• 00817830020678: Immunoassay for the detection of the following drug substance(s) in human urine: BZD
• 00817830020661: Immunoassay for the detection of the following drug substance(s) in human urine: BAR
• 00817830020654: Immunoassay for the detection of the following drug substance(s) in human urine: AMP