Home GUDID B07609700 LZI Fentanyl III Enzyme Immunoassay
Primary DI B07609700
Brand LZI Fentanyl III Enzyme Immunoassay
Company LIN-ZHI INTERNATIONAL, INC.
Model 0970
Catalog number 0970
Device description Small Test Kit. Antibody/Substrate Reagent (R1): 100 mL Enzyme Conjugate Reagent (R2): 37.5 mL
Published 2026-07-17
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false 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 B07609700 Primary HIBCC 0
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 0 0
Regulatory Flags# DUNS number 840839190 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B07609710 LZI Fentanyl III Enzyme Immunoassay 0971 0971 2026-07-17 B07609730 LZI Fentanyl Cutoff Calibrator 0973 0973 2026-07-17 B07609770 LZI Fentanyl Level 1 Control 0977 0977 2026-07-17 B07609780 LZI Fentanyl Level 2 Control 0978 0978 2026-07-17 00850624008643 Fentanyl II Enzyme Immunoassay 10427531190 10427531190 2025-11-17 00850624008544 LZI Fentanyl III Enzyme Immunoassay C82916 C82916 2025-10-13 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
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