Identify Health Drug Testing Device Test Cups ID-H13-1

GUDID 01085072100710

13 Panel CLIA Waived Cup - Identify Health AMP500, BAR300, BUP10, BZO300, COC150, MTD300, MDMA500, MET500, OPI300, OXY100, PCP25, TCA1000, THC50 3mm Strip - 25 Pack Box.

MEDICAL DISTRIBUTION GROUP INC

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

• Primary Device ID: 01085072100710
• NIH Device Record Key: fd160771-fe11-41d1-9961-7e1112957978
• Commercial Distribution Discontinuation: 2020-01-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Identify Health Drug Testing Device Test Cups
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: true

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
• 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	00850721007105 [Unit of Use]
GS1	01085072100710 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-01-09
• Device Publish Date: 2019-08-30

Devices Manufactured by MEDICAL DISTRIBUTION GROUP INC

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• 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
• 00850013035519 - Identify Health Drug Screen Test Cup: 2024-08-30 Identify Health Drug Screen Test Cup AMP500/COC150/OPI300/OXY100/PCP25,THC50
• 00850013035502 - Identify Health: 2023-12-15 Identify Health Drug Test Dip Card - AMP500/BAR300/BUP10/BZO300/COC150/MET500/MTD300/OPI300/OXY100/THC50
• 00850013035212 - Identify® Diagnostics Drug Test Cups: 2023-11-23 12-Panel Drug Screening Test Cup THC/COC/MOP/AMP/MET/PCP/MDMA/BAR/BZO/MTD/BUP/OXY
• 00850013035304 - Identify Health: 2023-08-11 Identify Health 4 Panel Drug Test Dip- CLIA Waived AMP500, COC150, MOP300, PCP25 Approx. 3.0mm strip 25 Tests/Box
• 00850013035205 - Bicycle Health: 2023-08-01 Bicycle Health 9 Panel Drug Test cup - CLIA Waived AMP500, BAR300, BUP10, BZO300, COC150, MTD300, MET500, MOR/OPI300, OXY100, (N
• 00850013035199 - Identify Health: 2023-05-19 Identify Health 9 Panel Drug Test cup - CLIA Waived AMP500, BAR300, BUP10, BZO300, COC150, MTD300, MET500, MOR/OPI300, OXY100, (