Identify Health Drug Screen Test Cup BC-US1-BUP-1-AZ25

GUDID 00850013037001

Boulder Care, Inc., 1 Panel Drug Screen Test Cup, CLIA WAIVED - MADE IN USA (BUP10) Contents: Test Cups - 25, Package Insert - 1, Security Seals – 25. For In Vitro Diagnostics Use Only.

MEDICAL DISTRIBUTION GROUP INC

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

• Primary Device ID: 00850013037001
• NIH Device Record Key: 92a70588-1e87-4c3d-9cd0-5d9484846618
• Commercial Distribution Discontinuation: 2025-12-04
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Identify Health Drug Screen Test Cup
• Version Model Number: BC-US1-BUP-1-AZ25
• Catalog Number: BC-US1-BUP-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: 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
GS1	00850013037001 [Unit of Use]
GS1	10850013037008 [Primary]

FDA Product Code

• DJG: Enzyme Immunoassay, Opiates

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-12-05
• Device Publish Date: 2025-10-31

On-Brand Devices [Identify Health Drug Screen Test Cup]

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• 20850721007857: Identify Health Drug Screen Test Cup AMP500/BZO300/COC150/OPI300/OXY100/THC50
• 20850721007840: Identify Health Drug Screen Test Cup AMP500/BAR300/BUP10/BZO300/COC150/MET500/ MTD300/OPI300/OXY
• 20850721007833: Identify Health Drug Screen Test Cup AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/ MET500/MTD300/OP
• 00850013035519: Identify Health Drug Screen Test Cup AMP500/COC150/OPI300/OXY100/PCP25,THC50
• 00850013036004: Identify Health 6 Panel Drug Screen Test Cup - CLIA Waived AMP500, COC150, MET500, OPI300, PCP2
• 00850013037001: Boulder Care, Inc., 1 Panel Drug Screen Test Cup, CLIA WAIVED - MADE IN USA (BUP10) Contents: Te