Nano-CheckTM Nicotine 500 AD6183

GUDID 00895160002366

In Vitro Diagnostic Test kit for the detection of Cotinine in human urine

NANO-DITECH CORPORATION

Cotinine (nicotine metabolite) IVD, reagent
Primary Device ID00895160002366
NIH Device Record Key92a5a676-26ea-453b-a6c2-beec248b8b91
Commercial Distribution StatusIn Commercial Distribution
Brand NameNano-CheckTM Nicotine 500
Version Model NumberAD6183
Catalog NumberAD6183
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 Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone609-409-3300
Emailinfo@nanoditech.com
Phone609-409-3300
Emailinfo@nanoditech.com
Phone609-409-3300
Emailinfo@nanoditech.com
Phone609-409-3300
Emailinfo@nanoditech.com
Phone609-409-3300
Emailinfo@nanoditech.com
Phone609-409-3300
Emailinfo@nanoditech.com
Phone609-409-3300
Emailinfo@nanoditech.com
Phone609-409-3300
Emailinfo@nanoditech.com
Phone609-409-3300
Emailinfo@nanoditech.com
Phone609-409-3300
Emailinfo@nanoditech.com
Phone609-409-3300
Emailinfo@nanoditech.com
Phone609-409-3300
Emailinfo@nanoditech.com
Phone609-409-3300
Emailinfo@nanoditech.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100895160002366 [Primary]
GS110895160002363 [Unit of Use]

FDA Product Code

MKUEnzyme Immunoassay, Nicotine And Nicotine Metabolites

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-06-29
Device Publish Date2016-10-04

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00895160002359 - Nano-CheckTM Nicotine2023-06-29 In Vitro Diagnostic Test kit for the detection of Cotinine in human urine
00895160002366 - Nano-CheckTM Nicotine 5002023-06-29In 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

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