Premier Bio-Cup & Bio-Dip PBCard-05-02

GUDID B313PBCARD05021

AMP500/COC150/MET500/OPI300/THC50

PREMIER BIOTECH, INC

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

• Primary Device ID: B313PBCARD05021
• NIH Device Record Key: 8fa3ccc2-726f-43ed-baa3-bd827fdabdc8
• Commercial Distribution Discontinuation: 2080-01-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premier Bio-Cup & Bio-Dip
• Version Model Number: PBCard-05-02
• Catalog Number: PBCard-05-02
• 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: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B313PBCARD05020 [Unit of Use]
HIBCC	B313PBCARD05021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122809

FDA Product Code

• LDJ: Enzyme Immunoassay, Cannabinoids

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-25

On-Brand Devices [Premier Bio-Cup & Bio-Dip]

• B313PBCUPA12191: AMP500/BAR300/BUP10/BZO300/COC150/EDDP300/MDMA500/MET500/OPI300/OXY100/PCP25/THC50/(OX/pH/SG)
• B313PBCUPA10321: AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI300/PCP25/PPX300/THC50/(OX/pH/SG)
• B313PBCUPA09061: AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI2000/PCP25/THC50/(OX/pH/SG)
• B313PBCUPA05021: AMP500/COC150/MET500/OPI300/THC50/(OX/pH/SG)
• B313PBCUP13011: AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/TCA1000/THC50
• B313PBCUP12191: AMP500/BAR300/BUP10/BZO300/COC150/EDDP300/MDMA500/MET500/OPI300/OXY100/PCP25/THC50
• B313PBCUP12021: AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/THC50
• B313PBCUP10331: AMP500/BAR300/BZO300/COC150/MTD300/OPI2000/OXY100/PCP25/PPX300/THC50
• B313PBCUP10321: AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI300/PCP25/PPX300/THC50
• B313PBCUP10201: AMP500/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/THC50
• B313PBCUP10061: AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI2000/PCP25/PPX300/THC50
• B313PBCUP10041: AMP1000/BZO300/COC300/MDMA500/MET1000/MTD300/OPI2000/OXY100/PCP25/THC50
• B313PBCUP09061: AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI2000/PCP25/THC50
• B313PBCUP07091: AMP500/BUP10/COC150/MET500/OPI300/OXY100/THC50
• B313PBCUP06231: AMP500/COC150/MDMA500/OPI300/OXY100/THC50
• B313PBCUP06041: AMP500/COC150/MET500/OPI300/PCP25/THC50
• B313PBCUP06011: AMP500/BZO300/COC150/MET500/OPI300/THC50
• B313PBCUP05091: AMP500/COC150/OPI2000/PCP25/THC50
• B313PBCUP05041: COC150/MET500/OPI300/OXY100/THC50
• B313PBCUP05021: AMP500/COC150/MET500/OPI300/THC50
• B313PBCUP04141: COC150/MET500/OPI300/OXY100
• B313PBCUP04131: AMP500/COC150/OPI300/OXY100
• B313PBCUP04091: BZO300/COC150/OPI300/THC50
• B313PBCUP03061: COC150/OPI300/THC50
• B313PBCUP03041: AMP500/COC150/OPI300
• B313PBCARDM10201: (AMP500/OPI300)/(COC150/THC50)/BUP10/BZO300/MDMA500/MET500/MTD300/OXY100
• B313PBCARDAM07251: (AMP500/OPI300)/(COC150/THC50)/(MET500/PCP25)/OXY100/(OX/pH/SG)
• B313PBCARDA12191: AMP500/BAR300/BUP10/BZO300/COC150/EDDP300/MDMA500/MET500/OPI300/OXY100/PCP25/THC50/(OX/pH/SG)
• B313PBCARDA10321: AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI300/PCP25/PPX300/THC50/(OX/pH/SG)
• B313PBCARDA09061: AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI2000/PCP25/THC50/(OX/pH/SG)
• B313PBCARDA05021: AMP500/COC150/MET500/OPI300/THC50/(OX/pH/SG)
• B313PBCARD13011: AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/TCA1000/THC50
• B313PBCARD12191: AMP500/BAR300/BUP10/BZO300/COC150/EDDP300/MDMA500/MET500/OPI300/OXY100/PCP25/THC50
• B313PBCARD12021: AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/THC50
• B313PBCARD10331: AMP500/BAR300/BZO300/COC150/MTD300/OPI2000/OXY100/PCP25/PPX300/THC50
• B313PBCARD10321: AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI300/PCP25/PPX300/THC50
• B313PBCARD10201: AMP500/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/THC50
• B313PBCARD10061: AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI2000/PCP25/PPX300/THC50
• B313PBCARD10041: AMP1000/BZO300/COC300/MDMA500/MET1000/MTD300/OPI2000/OXY100/PCP25/THC50
• B313PBCARD09061: AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI2000/PCP25/THC50
• B313PBCARD07091: AMP500/BUP10/COC150/MET500/OPI300/OXY100/THC50
• B313PBCARD06231: AMP500/COC150/MDMA500/OPI300/OXY100/THC50
• B313PBCARD06041: AMP500/COC150/MET500/OPI300/PCP25/THC50
• B313PBCARD06011: AMP500/BZO300/COC150/MET500/OPI300/THC50
• B313PBCARD05091: AMP500/COC150/OPI2000/PCP25/THC50
• B313PBCARD05041: COC150/MET500/OPI300/OXY100/THC50
• B313PBCARD05021: AMP500/COC150/MET500/OPI300/THC50
• B313PBCARD04171: COC150/MDMA500/OPI300/THC50
• B313PBCARD04161: COC150/MET500/PCP25/THC50
• B313PBCARD04091: BZO300/COC150/OPI300/THC50