Identify Health ID-H12-2

GUDID 01085072100703

Identify Health Drug Screen Test Cup AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/ MET500/MTD300/OPI300/OXY100/TCA1000/THC50

MEDICAL DISTRIBUTION GROUP INC

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

• Primary Device ID: 01085072100703
• NIH Device Record Key: aaa7b2ea-86e4-450a-b413-c83c1dd120bb
• Commercial Distribution Discontinuation: 2020-01-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Identify Health
• Version Model Number: ID-H12-2
• Catalog Number: ID-H12-2
• 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

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
• 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	00850721007839 [Unit of Use]
GS1	01085072100703 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122809

FDA Product Code

• LFG: Radioimmunoassay, Tricyclic Antidepressant Drugs

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: 2020-01-09
• Device Publish Date: 2019-08-26

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