BioTech Screening CI-565

GUDID 10863112000309

6-Panel T-Cup; AMP/BZO/COC/MET/MOP/OXY

BIOTECH SCREENING LLC

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• Primary Device ID: 10863112000309
• NIH Device Record Key: cf1f3fe1-52fe-4258-a46f-fab66f811162
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioTech Screening
• Version Model Number: CI-565
• Catalog Number: CI-565
• Company DUNS: 962374968
• Company Name: BIOTECH SCREENING LLC
• Device Count: 25
• 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: true

Customer Support Contacts

• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com
• Phone: (925) 899-0615
• Email: jim@biotechscreening.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863112000302 [Primary]
GS1	00863112000340 [Unit of Use]
GS1	10863112000309 [Package]; Contains: 00863112000302; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133968

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: 2016-10-26

On-Brand Devices [BioTech Screening]

• 00863112000364: 7-Panel T-Cup; AMP/BZO/COC/MET/MOP/OXY/THC
• 10863112000323: 7-Panel T-Cup; AMP/MET/BZO/BUP/COC/OPI/THC
• 10863112000316: 7-Panel T-Cup; COC/OXY/BZO/OPI/MET/AMP/THC
• 10863112000309: 6-Panel T-Cup; AMP/BZO/COC/MET/MOP/OXY