Nano-CheckTM DAT 4M AD405U

GUDID 00895160002540

In Vitro Diagnostic Test kit for the detection of Tricyclic antidepressant, Amphetamine, Methamphetamine, and Opiate in human urine.

NANO-DITECH CORPORATION

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

• Primary Device ID: 00895160002540
• NIH Device Record Key: 3726eb36-fa23-4dea-9406-71d7c908ffc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nano-CheckTM DAT 4M
• Version Model Number: AD405U
• Catalog Number: AD405U
• Company DUNS: 126544316
• Company Name: NANO-DITECH CORPORATION
• 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: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com
• Phone: 1-609-409-3300
• Email: info@nanoditech.com

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	00895160002540 [Primary]
GS1	10895160002547 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050594

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: 2018-12-17

On-Brand Devices [Nano-CheckTM DAT 4M]

• 00895160002564: In Vitro Diagnostic Test kit for the detection of Tricyclic antidepressant, Amphetamine, Methamp
• 00895160002540: In Vitro Diagnostic Test kit for the detection of Tricyclic antidepressant, Amphetamine, Methamp