Home GUDID 80810164510071
Atida Fentanyl Drug of Abuse Test Rx
Primary DI 80810164510071
Brand Atida Fentanyl Drug of Abuse Test Rx
Company ACESO LABORATORIES INC.
Model U02-FYL-US
Device description 25T, FDA
Published 2026-03-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile false
Single use 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 00810164510075 Primary GS1 0 80810164510071 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 00810164510075 00810164510075 810164510075 0810164510075 80810164510071 80810164510071
GMDN Terms# Term, Definition table Term Definition Fentanyl IVD, kit, rapid ICT, clinical A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of fentanyl in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
Regulatory Flags# DUNS number 003099455 Device count 25 DM exempt false Premarket exempt false HCT/P false Kit false 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 00810164510013 ACESO Early Pregnancy Test U03ST-UHCG-US 2026-03-23 00810164510020 ACESO Early Pregnancy Test U03ST-UHCG-US 2026-03-23 00810164510037 ACESO Early Pregnancy Test U03ST-UHCG-US 2026-03-23 00810164510044 ACESO Early Pregnancy Test U03ST-UHCG-US 2026-03-23 00810164510051 ACESO Early Pregnancy Test U03ST-UHCG-US 2026-03-23 00810164510068 ACESO Early Pregnancy Test U03ST-UHCG-US 2026-03-23 00810164510075 Atida Fentanyl Drug of Abuse Test Rx U02-FYL-US 2026-03-23 00810164510082 Atida Fentanyl Drug of Abuse Test U02CW-FYL-US 2026-03-23 00810164510105 Atida hCG Pregnancy Rapid Combo Test US02-HCG-US 2026-03-23 00810164510730 Atida Marijuana (THC) Drug of Abuse Strip Test Rx U01CW-THC-US 2026-03-23 00810164510747 Atida Marijuana (THC) Drug of Abuse Rapid Urine Dip Card U04CW-THC-US 2026-03-23 00810164510815 Atida Viral Transport Medium (Non-inactivated Type) Q01-VTM-US 2026-03-23 00810164510006 ACESO Early Pregnancy Test U03ST-UHCG-US 2026-03-23 80810164510019 ACESO Early Pregnancy Test U03ST-UHCG-US 2026-03-23 80810164510026 ACESO Early Pregnancy Test U03ST-UHCG-US 2026-03-23 80810164510033 ACESO Early Pregnancy Test U03ST-UHCG-US 2026-03-23 80810164510040 ACESO Early Pregnancy Test U03ST-UHCG-US 2026-03-23 80810164510057 ACESO Early Pregnancy Test U03ST-UHCG-US 2026-03-23 80810164510064 ACESO Early Pregnancy Test U03ST-UHCG-US 2026-03-23 80810164510088 Atida Fentanyl Drug of Abuse Test U02CW-FYL-US 2026-03-23
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