Home GUDID 00850624008544 LZI Fentanyl III Enzyme Immunoassay
Primary DI 00850624008544
Brand LZI Fentanyl III Enzyme Immunoassay
Company LIN-ZHI INTERNATIONAL, INC.
Model C82916
Catalog number C82916
Device description Large Test Kit.Antibody/Substrate Reagent (R1): 1000 mLEnzyme Conjugate Reagent (R2): 375 mL
Published 2025-10-13
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name DJG Enzyme Immunoassay, Opiates
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DJG Enzyme Immunoassay, Opiates Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850624008544 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850624008544 00850624008544 850624008544 0850624008544
GMDN Terms# Term, Definition table Term Definition Fentanyl IVD, kit, enzyme immunoassay (EIA) A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of fentanyl in a clinical specimen, using an enzyme immunoassay (EIA) method.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 840839190 Device count 1 Kit true Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850624008643 Fentanyl II Enzyme Immunoassay 10427531190 10427531190 2025-11-17 00850624008650 LZI Fentanyl Qualitative Calibrator D26784 D26784 2025-10-13 00850624008667 LZI Fentanyl Level 1 Control D26785 D26785 2025-10-13 00850624008674 LZI Fentanyl Level 2 Control D26786 D26786 2025-10-13 00850624008681 LZI Fentanyl III Enzyme Immunoassay D29739 D29739 2025-10-13 00850624008636 Fentanyl Control Set 10426667190 10426667190 2025-06-06 B07600400 Amphetamines Enzyme Immunoassay 0040 0040 2016-07-05 B07600410 Amphetamines Enzyme Immunoassay 0041 0041 2016-07-05 B07601000 Amphetamines 500 Enzyme Immunoassay 0100 0100 2016-07-05 B07601010 Amphetamines 500 Enzyme Immunoassay 0101 0101 2016-07-05 B07601600 Ecstasy Enzyme Immunoassay 0160 0160 2016-07-05 B07601610 Ecstasy Enzyme Immunoassay 0161 0161 2016-07-05 B07601620 Ecstasy DAU Calibrator, Low Calibrator 0162 0162 2016-07-05 B07601630 Ecstasy DAU Calibrator, Cutoff Calibrator 0163 0163 2016-07-05 B07601640 Ecstasy DAU Calibrator, Intermediate Calibrator 0164 0164 2016-07-05 B07601650 Ecstasy DAU Calibrator, High Calibrator 0165 0165 2016-07-05 B07601670 Ecstasy DAU Control, Level 1 Control 0167 0167 2016-07-05 B07601680 Ecstasy DAU Control, Level 2 Control 0168 0168 2016-07-05 B0760002C0 Cannabinoids DAU Calibrator, Negative Calibrator 0002c 0002c 2016-07-05 B0760006C0 Cannabinoids DAU Control, Control 0006c 0006c 2016-07-05
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