OralTox

GUDID B313OT804011

4 Panel OralTox - AMP/COC/OPI/THC

PREMIER BIOTECH, INC

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

• Primary Device ID: B313OT804011
• NIH Device Record Key: 864ee37b-ad96-41c2-b344-c6a54e9179de
• Commercial Distribution Discontinuation: 2020-01-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OralTox
• Version Model Number: OT80401
• 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	B313OT804010 [Unit of Use]
HIBCC	B313OT804011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171403

FDA Product Code

• LDG: Kit, Earmold, Impression

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: 2018-10-25
• Device Publish Date: 2018-09-24

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