Premier Biotech PCU-13FCW-25

GUDID 00812203030773

13-Panel DOA Cup, AMP500/BAR/BUP/BZO/COC150/FYL5/MET500/MDMA/MOR/MTD/OXY/PCP/THC, 25tests/kit

CHEMTRON BIOTECH INC

Multiple drugs of abuse IVD, kit, rapid ICT, clinical

• Primary Device ID: 00812203030773
• NIH Device Record Key: 89452d32-1424-44b6-a887-503258e51d1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premier Biotech
• Version Model Number: PCU-13FCW-25
• Catalog Number: PCU-13FCW-25
• Company DUNS: 795658603
• Company Name: CHEMTRON BIOTECH INC
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812203030773 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232736

FDA Product Code

• LDJ: Enzyme Immunoassay, Cannabinoids

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: 2024-06-05
• Device Publish Date: 2024-05-28

On-Brand Devices [Premier Biotech]

• 00812203030315: 14-Panel DOA Cup, THC/COC150/MOR/MET500/AMP500/BZO/BAR/MTD/BUP/TCA/MDMA/OXY/PCP/PPX
• 00812203030490: 12-panel DOA Cup AMP500/BAR/BZO/COC150/MDMA/MET500/MTD/OPI300/OXY/PCP/PPX/THC (Ox/pH/SG) - PB
• 00812203030353: 12-panel DOA Cup AMP500/BAR/BZO/COC150/MDMA/MET500/MTD/OPI300/OXY/PCP/PPX/THC (Cr/Ox/pH) - PB
• 00812203030506: 10 Panel Cup, AMP500/BAR/BZO/COC150/MET500/MTD/OPI300/PCP/PPX/THC(Ox/pH/SG)
• 00812203030360: Premier Biotech 10-Panel DOA Cup, AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI300/PCP25/PPX300/
• 00812203030568: 10 Panel Cup W/ AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/(Cr/Ox/pH)
• 00812203030575: 6 Panel Cup W/ AMP500/COC150/MET500/OPI300/PCP25/THC50(Cr/Ox/pH)
• 00812203030582: 6 Panel Cup W/ AMP500/COC150/MET500/OPI300/PCP25/THC50(Cr/Ox/pH)
• 00812203030735: 14-Panel DOA Cup, AMP500/BAR/BUP/BZO/COC150/FYL5/MET500/MDMA/MOR/MTD/OXY/PCP/THC/TML + A-strip (
• 00812203030773: 13-Panel DOA Cup, AMP500/BAR/BUP/BZO/COC150/FYL5/MET500/MDMA/MOR/MTD/OXY/PCP/THC, 25tests/kit
• 00812203030766: 10-Panel DOA Cup, AMP500/BUP/BZO/COC150/FYL5/MET500/MOR/MTD/OXY/THC, 25tests/kit