Identify Health ID-H13-1

GUDID 10850013035028

13 Panel CLIA Waived Cup - Identify Health AMP500, BAR300, BUP10, BZO300, COC150, MTD300, MDMA500, MET500, OPI300, OXY100, PCP25, TCA1000, THC50 3mm Strip

MEDICAL DISTRIBUTION GROUP INC

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

• Primary Device ID: 10850013035028
• NIH Device Record Key: fd7fdeda-6179-4c2f-9b8c-e6303b62ac6f
• Commercial Distribution Discontinuation: 2050-01-08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Identify Health
• Version Model Number: ID-H13-1
• Catalog Number: ID-H13-1
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850721007105 [Unit of Use]
GS1	10850013035028 [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: 2020-01-16
• Device Publish Date: 2020-01-08

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