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

Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device ID10895160002240
NIH Device Record Key92934685-0039-4357-a6e3-cd5deb51570f
Commercial Distribution StatusIn Commercial Distribution
Brand NameNano-Check™ OPI Test
Version Model NumberAD4183
Company DUNS126544316
Company NameNANO-DITECH CORPORATION
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100895160002243 [Primary]
GS110895160002240 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-05
Device Publish Date2023-06-27

Devices Manufactured by NANO-DITECH CORPORATION

10895160002844 - Nano-Check Influenza+COVID-19 Dual Test2024-08-16 The Nano-Check™ Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay intended for in vitro rapid, simult
00895160002854 - Nano-Check RSV Test2024-08-16 The Nano-Check RSV Test is a rapid immunochromatographic assay for the qualitative detection of respiratory syncytial virus (RSV
10895160002868 - Nano-Check TM COVID-19 Antigen Test2024-04-09 An in vitro diagnostic lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2.
10895160002240 - Nano-Check™ OPI Test2023-07-05A 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 Test2023-07-05 A rapid, self-controlled, immunoassay for the qualitative detection of Heroin, Codeine, Morphine and Hydrocodone called opiates,
00895160002120 - Nano-CheckTM AMI 2 in 12023-06-29 In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I and Myoglobin in human whole blood, serum and plasma
00895160002359 - Nano-CheckTM Nicotine2023-06-29 In Vitro Diagnostic Test kit for the detection of Cotinine in human urine
00895160002366 - Nano-CheckTM Nicotine 5002023-06-29 In Vitro Diagnostic Test kit for the detection of Cotinine in human urine
00895160002410 - Fluoro-CheckTM cTnI2023-06-29 Fluorescence in vitro diagnostic test kit for the detection of cardiac troponin I in human while blood, serum and plasma of myoc

Trademark Results [Nano-Check]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NANO-CHECK
NANO-CHECK
88099913 not registered Live/Pending
Nano-Ditech Corporation
2018-08-30
NANO-CHECK
NANO-CHECK
78895879 3610468 Dead/Cancelled
Nano-Ditech Corporation
2006-05-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.