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

• 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

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	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