MP DOA-3 TEST CUP 07RD7109-02

GUDID 00817830020289

Immunoassay for the detection of the following drug substance(s) in human urine: THC / COC / AMP

RAPID DIAGNOSTICS INC

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

• Primary Device ID: 00817830020289
• NIH Device Record Key: e3a3cc42-87ea-4d3b-95d6-77dd1dc3beb9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MP DOA-3 TEST CUP
• Version Model Number: 07RD7109-02
• Catalog Number: 07RD7109-02
• 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

• Height: 74 Millimeter
• Height: 74 Millimeter
• Height: 74 Millimeter
• Height: 74 Millimeter
• Height: 74 Millimeter
• Height: 74 Millimeter
• Height: 74 Millimeter
• Height: 74 Millimeter
• Height: 74 Millimeter
• Height: 74 Millimeter
• Height: 74 Millimeter
• Height: 74 Millimeter
• Height: 74 Millimeter
• Height: 74 Millimeter
• Height: 74 Millimeter
• Height: 74 Millimeter
• Height: 74 Millimeter
• Height: 74 Millimeter
• Height: 74 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	00817830020289 [Primary]

FDA Product Code

• DIO: ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES

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

Devices Manufactured by RAPID DIAGNOSTICS INC

• 00817830020029 - RAPID DIAGNOSTICS M-AMPHAMPHETAMINE TEST STRIP: 2018-03-29 M-AMPHAMPHETAMINE TEST STRIP
• 00817830020036 - RAPID DIAGNOSTICS COCAINE TEST STRIP: 2018-03-29 COCAINE TEST STRIP
• 00817830020050 - RAPID DIAGNOSTICS OPIATES TEST STRIP: 2018-03-29 OPIATES TEST STRIP
• 00817830020074 - RAPID DIAGNOSTICS BARBITURATE TEST STRIP: 2018-03-29 BARBITURATE TEST STRIP
• 00817830020081 - RAPID DIAGNOSTICS BENZODIAZEPINE TEST STRIP: 2018-03-29 BENZODIAZEPINE TEST STRIP
• 00817830020098 - RAPID DIAGNOSTICS METHADONE TEST STRIP: 2018-03-29 METHADONE TEST STRIP
• 00817830020104 - RAPID DIAGNOSTICS PCP TEST STRIP: 2018-03-29 PCP TEST STRIP
• 00817830020111 - RAPID DIAGNOSTICS OPI/MOR TEST STRIP - 2000: 2018-03-29 OPI/MOR TEST STRIP - 2000