Home GUDID 00895160002359 Nano-CheckTM Nicotine
Primary DI 00895160002359
Brand Nano-CheckTM Nicotine
Company NANO-DITECH CORPORATION
Model AD6083
Catalog number AD6083
Device description In Vitro Diagnostic Test kit for the detection of Cotinine in human urine
Published 2016-09-12
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name MKU Enzyme Immunoassay, Nicotine And Nicotine Metabolites
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MKU Enzyme Immunoassay, Nicotine And Nicotine Metabolites Clinical Toxicology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00895160002359 Primary GS1 0 10895160002356 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00895160002359 00895160002359 895160002359 0895160002359 10895160002356 10895160002356
GMDN Terms# Term, Definition table Term Definition Cotinine (nicotine metabolite) IVD, reagent A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of cotinine (nicotine metabolite) in a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 126544316 Device count 25 Kit true Lot or batch true Manufacturing date on label true Expiration date on label true Donation ID number true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10722066008376 Rapid Response BTNX Inc MKU 2024-08-14 00722066008379 Rapid Response BTNX Inc MKU 2024-08-14 10722066008369 Rapid Response BTNX Inc MKU 2024-02-26 00810124273309 SureStep™ Urine Test Drug Screen Cassette, Cotinine (COT 200) Alere San Diego, Inc. MKU 2023-12-15 10810124273306 SureStep™ Urine Test Drug Screen Cassette, Cotinine (COT 200) ALERE SAN DIEGO, INC. MKU 2023-12-15 B07605200 LZI Cotinine II Enzyme Immunoassay LIN-ZHI INTERNATIONAL, INC. MKU 2022-04-22 B07605210 LZI Cotinine II Enzyme Immunoassay LIN-ZHI INTERNATIONAL, INC. MKU 2022-04-22 00608337000030 Kit, MP Cotinine Serum 100 plate Orasure Technologies, Inc. MKU 2021-01-22 00859410006092 Salimetrics SALIMETRICS, LLC MKU 2018-09-14 00859410006108 Salimetrics SALIMETRICS, LLC MKU 2018-09-14 00884883001077 DRI Cotinine Low Control Microgenics Corporation MKU 2017-10-18 00884883001084 DRI Cotinine High Control Microgenics Corporation MKU 2017-10-18 00895160002366 Nano-CheckTM Nicotine 500 NANO-DITECH CORPORATION MKU 2016-10-04 00884883002876 DRI Cotinine Assay Microgenics Corporation MKU 2016-09-24 10743816000235 AccuSign® Nicotine card PRINCETON BIOMEDITECH CORPORATION MKU 2016-09-23 10743816000242 Status™ Nicotine card PRINCETON BIOMEDITECH CORPORATION MKU 2016-09-23 00884883001053 DRI Cotinine Assay Microgenics Corporation MKU 2016-09-22 00884883001060 DRI Cotinine Calibrator Kit Microgenics Corporation MKU 2016-09-22 00608337000399 Cotinine Serum 5 Plate Kit Orasure Technologies, Inc. MKU 2016-09-16 00608337000405 Cotinine Serum 2 Plate Kit Orasure Technologies, Inc. MKU 2016-09-16 00608337000665 Cotinine OraSure 5 Plate Kit Orasure Technologies, Inc. MKU 2016-09-16 00608337000672 Cotinine OraSure 100 Plate Kit Orasure Technologies, Inc. MKU 2016-09-16 00884883012905 DRI Cotinine Assay Microgenics Corporation MKU 2016-09-12 00608337000085 Auto-Lyte Orasure Technologies, Inc. MKU 2016-04-29 00608337000474 Auto-Lyte Orasure Technologies, Inc. MKU 2016-04-29
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