Identify Health ID-H12-1

GUDID 10850721007829

Identify Health Drug Screen Test Cup AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/ MET500/MTD300/OPI300/OXY100/PCP25/THC50

MEDICAL DISTRIBUTION GROUP INC

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

• Primary Device ID: 10850721007829
• NIH Device Record Key: e5e457c5-c177-43b5-9db8-c9b1bfac8c73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Identify Health
• Version Model Number: ID-H12-1
• Catalog Number: ID-H12-1
• 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	00850721007822 [Unit of Use]
GS1	10850721007829 [Primary]
GS1	20850721007826 [Package]; Package: case [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122809

FDA Product Code

• DJC: Thin Layer Chromatography, Methamphetamine

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: 2021-05-24
• Device Publish Date: 2019-02-27

On-Brand Devices [Identify Health]

• 10850721007911: Identify Health Drug Test Dip Card- THC (50) Cannabinoids 50 ng/ml
• 10850721007904: Identify Health Drug Test Dip Card- COC (150) Cocaine 150 ng/ml
• 10850721007928: Identify Health Drug Test - CLIA Waived 8 Panel Dip Card (COC150/MOP300/AMP500/MET500/BZO300/MT
• 01085072100703: Identify Health Drug Screen Test Cup AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/ MET500/MTD300/OP
• 10850013035035: Identify Health Drug Screen Test Cup AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/ MET500/MTD300/OP
• 10850013035028: 13 Panel CLIA Waived Cup - Identify Health AMP500, BAR300, BUP10, BZO300, COC150, MTD300, MDMA50
• 00850013035038: Identify Health 5 Panel Drug Test Cup - CLIA Waived COC150/MET500/OPI300/OXY100/THC50 3mm Strip,
• 10850721007829: Identify Health Drug Screen Test Cup AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/ MET500/MTD300/OP
• 00850721007990: 12 Panel CLIA Waived Cup w/ 3 AD - Identify Health AMP500, BAR300, BUP10, BZO300, COC150, MTD300
• 00850013035182: Identify Health 14 Panel CLIA Waived Cup with 6 Adulterations- AMP500, BAR300, BUP10, BZO300, CO
• 00850013035199: Identify Health 9 Panel Drug Test cup - CLIA Waived AMP500, BAR300, BUP10, BZO300, COC150, MTD30
• 00850013035304: Identify Health 4 Panel Drug Test Dip- CLIA Waived AMP500, COC150, MOP300, PCP25 Approx. 3.0mm s
• 00850013035502: Identify Health Drug Test Dip Card - AMP500/BAR300/BUP10/BZO300/COC150/MET500/MTD300/OPI300/OXY1