OralTox

GUDID B313OT804021

4 Panel OralTox - COC/MET/OPI/OXY

PREMIER BIOTECH, INC

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

• Primary Device ID: B313OT804021
• NIH Device Record Key: 2f7b2b6e-2b91-48f4-9fee-c1ccf8bdbef9
• Commercial Distribution Discontinuation: 2020-01-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OralTox
• Version Model Number: OT80402
• Company DUNS: 010118759
• Company Name: PREMIER BIOTECH, INC
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B313OT804020 [Unit of Use]
HIBCC	B313OT804021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181305

FDA Product Code

• DJG: Enzyme Immunoassay, Opiates

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-29
• Device Publish Date: 2018-09-27

On-Brand Devices [OralTox]

• B313OT808071: 8 Panel OralTox - AMP/COC/MET/MTD/OPI/OXY/PCP/THC
• B313OT807011: 7 Panel OralTox - AMP/COC/MET/OPI/OXY/PCP/THC
• B313OT806221: OralTox 6 Panel - COC/MET/OPI/OXY/PCP/THC
• B313OT806051: 6 Panel OralTox - AMP/COC/MET/OPI/OXY/THC
• B313OT806021: 6 Panel OralTox - AMP/COC/MET/OPI/PCP/THC
• B313OT805101: 5 Panel OralTox - COC/MET/OPI/OXY/THC
• B313OT805091: 5 Panel OralTox Device - COC/MET/OPI/OXY/THC
• B313OT805081: 5 Panel OralTox - AMP/COC/MET/OPI/THC
• B313OT805041: 5 Panel OralTox - AMP/COC/OPI/PCP/THC
• B313OT805021: 5 Panel OralTox - AMP/COC/MET/OPI/THC
• B313OT804041: 4 Panel OralTox - AMP/COC/OPI/PCP
• B313OT804021: 4 Panel OralTox - COC/MET/OPI/OXY
• B313OT804011: 4 Panel OralTox - AMP/COC/OPI/THC