Nano-Check™ OPI Test

GUDID 10895160002240

A rapid, self-controlled, immunoassay for the qualitative detection of Heroin, Codeine, Morphine and Hydrocodone called opiates, in human urine. The detection limit (Cut off concentration) of this test is at 300 ng/ml of morphine.

NANO-DITECH CORPORATION

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• Primary Device ID: 10895160002240
• NIH Device Record Key: 92934685-0039-4357-a6e3-cd5deb51570f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nano-Check™ OPI Test
• Version Model Number: AD4183
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00895160002243 [Primary]
GS1	10895160002240 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-05
• Device Publish Date: 2023-06-27

Devices Manufactured by NANO-DITECH CORPORATION

• 10895160002868 - Nano-Check TM COVID-19 Antigen Test: 2024-04-09 An in vitro diagnostic lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2.
• 10895160002240 - Nano-Check™ OPI Test: 2023-07-05A rapid, self-controlled, immunoassay for the qualitative detection of Heroin, Codeine, Morphine and Hydrocodone called opiates, in human urine. The detection limit (Cut off concentration) of this test is at 300 ng/ml of morphine.
• 10895160002240 - Nano-Check™ OPI Test: 2023-07-05 A rapid, self-controlled, immunoassay for the qualitative detection of Heroin, Codeine, Morphine and Hydrocodone called opiates,
• 00895160002120 - Nano-CheckTM AMI 2 in 1: 2023-06-29 In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I and Myoglobin in human whole blood, serum and plasma
• 00895160002359 - Nano-CheckTM Nicotine: 2023-06-29 In Vitro Diagnostic Test kit for the detection of Cotinine in human urine
• 00895160002366 - Nano-CheckTM Nicotine 500: 2023-06-29 In Vitro Diagnostic Test kit for the detection of Cotinine in human urine
• 00895160002410 - Fluoro-CheckTM cTnI: 2023-06-29 Fluorescence in vitro diagnostic test kit for the detection of cardiac troponin I in human while blood, serum and plasma of myoc
• 00895160002427 - Fluoro-CheckTM PCT: 2023-06-29 Fluorescence In Vitro diagnostic test kit for the detection of Procalcitonin in human whole blood, serum or plasma
• 00895160002434 - Fluoro-CheckTM NT-proBNP: 2023-06-29 Fluorescence In Vitro Diagnostic Test kit for the determination of NT-proBNP (N-terminal pro-Brain natriuretic peptide) in human