Bicycle Health ID-BH9-ADULT-1-AZ25

GUDID 00850013035205

Bicycle Health 9 Panel Drug Test cup - CLIA Waived AMP500, BAR300, BUP10, BZO300, COC150, MTD300, MET500, MOR/OPI300, OXY100, (NI/CR) Approx. 3mm Strip 25 Tests/Box

MEDICAL DISTRIBUTION GROUP INC

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

• Primary Device ID: 00850013035205
• NIH Device Record Key: 5d3dab67-35be-41dd-9481-df38d9827e43
• Commercial Distribution Discontinuation: 2045-07-03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bicycle Health
• Version Model Number: ID-BH9-ADULT-1-AZ25
• Catalog Number: ID-BH9-ADULT-1-AZ25
• Company DUNS: 064177324
• Company Name: MEDICAL DISTRIBUTION GROUP 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850013035205 [Unit of Use]
GS1	10850013035202 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122809

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: 2023-08-01
• Device Publish Date: 2023-07-24

Devices Manufactured by MEDICAL DISTRIBUTION GROUP INC

• 00850721007297 - Identify Diagnostics Drug Test Cups: 2025-09-19 12-Panel Drug Screening Test Cup THC/COC/MOP/AMP/MET/PCP/MDMA/BAR/BZO/MTD/BUP/OXY
• 00850721007501 - Identify® Diagnostics Drug Test Cards: 2025-09-19 Identify® Diagnostics Drug Test Cards 5 panel Drug Test Card AMP/COC/THC/MET/MOP
• 00850721007679 - Identify® Diagnostics Drug Test Cards: 2025-09-19 Identify® Diagnostics Drug Test Cards 5 Panel Drug Test Card AMP/COC/THC/MET/MOP
• 00850721007334 - Identify Diagnostics Drug Test Cups: 2025-09-19 6-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC
• 00850013035076 - Identify®Diagnostics Drug Test Cups: 2025-09-19 Identify® Diagnostics Drug Test Cups 10-Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MTD/MOP/PCP/OXY/THC
• 00850721007204 - Identify Diagnostics Drug Test Cups: 2025-09-19 10-Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MTD/MOP/PCP/OXY/THC
• 00850013035229 - Identify® Diagnostics Drug Test Cups: 2025-01-03 Identify® Diagnostics Drug Test Cups 9-Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MTD/OPI/OXY/PCP
• 00850013036004 - Identify Health Drug Screen Test Cup: 2024-11-28 Identify Health 6 Panel Drug Screen Test Cup - CLIA Waived AMP500, COC150, MET500, OPI300, PCP25 THC50 3mm Strip - 25 Pack Box