Instant Test Cup 10-300

GUDID 00816555021502

COC300, OPI300, AMP1000, MET1000, BZO300, OXY100 with adulteration OX/SG/pH drugs of abuse test cup (CLIA WAIVED)

BRANAN MEDICAL CORPORATION

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

• Primary Device ID: 00816555021502
• NIH Device Record Key: a7f79fa7-9939-4467-af76-d8e97464e731
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Instant Test Cup
• Version Model Number: 10-300
• Catalog Number: 10-300
• Company DUNS: 184347305
• Company Name: BRANAN MEDICAL CORPORATION
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com

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
• 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	00816555021502 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082898

FDA Product Code

• DJG: Enzyme Immunoassay, Opiates

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: 2018-07-06
• Device Publish Date: 2016-09-01

On-Brand Devices [Instant Test Cup]

• 00816555021502: COC300, OPI300, AMP1000, MET1000, BZO300, OXY100 with adulteration OX/SG/pH drugs of abuse test
• 00816555021496: COC300, OPI300, AMP1000, MET1000, PCP25, MDMA500, BAR300, BZO300, MTD300, TCA1000, OXY100 with a
• 00816555021489: THC50, COC300, OPI300, AMP1000, MET1000, PCP25, MDMA500, BAR300, BZO300, MTD300, TCA1000, OXY100