Instant Test Cup 10-100

GUDID 00816555021489

THC50, COC300, OPI300, AMP1000, MET1000, PCP25, MDMA500, BAR300, BZO300, MTD300, TCA1000, OXY100 drugs of abuse test cup (CLIA WAIVED)

BRANAN MEDICAL CORPORATION

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

• Primary Device ID: 00816555021489
• NIH Device Record Key: 0bcc0a86-dc9e-4f22-9010-c8f2bd259883
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Instant Test Cup
• Version Model Number: 10-100
• Catalog Number: 10-100
• 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	00816555021489 [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