BioTech Screening CI-575

GUDID 00863112000364

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

BIOTECH SCREENING LLC

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

• Primary Device ID: 00863112000364
• NIH Device Record Key: 48682f99-a21b-41f8-82c1-d6c55fc77674
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioTech Screening
• Version Model Number: CI-575
• Catalog Number: CI-575
• Company DUNS: 962374968
• Company Name: BIOTECH SCREENING LLC
• 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: 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
• 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
• 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	00863112000364 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133968

FDA Product Code

• LAF: Gas Chromatography, Methamphetamine

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: 2017-02-07

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