Home GUDID 00810174471229 Prime Screen®
Primary DI 00810174471229
Brand Prime Screen®
Company WONDFO USA CO., LTD.
Model DCDOA-L964-5BX-A
Device description Prime Screen Multi- Drug Urine Test Cup (6-Panel T-Cup Compact); 6- MAM10,AMP500,COC 150,OPI2000,PCP25,T HC50
Published 2026-06-26
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 LCM Enzyme Immunoassay, Phencyclidine NFT Test, Amphetamine, Over The Counter NFW Test, Cannabinoid, Over The Counter NFY Test, Cocaine And Cocaine Metabolites, Over The Counter NGL Test, Opiates, Over The Counter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LCM Enzyme Immunoassay, Phencyclidine Unknown U NFT Test, Amphetamine, Over The Counter Clinical Toxicology 2 NFW Test, Cannabinoid, Over The Counter Clinical Toxicology 2 NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology 2 NGL Test, Opiates, Over The Counter Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810174471229 Primary GS1 0 00810174471236 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 00810174471229 00810174471229 810174471229 0810174471229 00810174471236 00810174471236 810174471236 0810174471236
GMDN Terms# Term, Definition table Term Definition Multiple drugs of abuse 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 multiple drugs of abuse 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 849098897 Device count 5 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00817405024247 iScreen™ Instant Technologies, Inc. LCM 2026-08-01 00810173656719 Healgen Healgen Scientific Limited Liability Company LCM 2026-07-31 00840050500170 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500170 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500170 OneScreen AMERICAN SCREENING, L.L.C. NFW 2022-11-11 00840050500170 OneScreen AMERICAN SCREENING, L.L.C. NFT 2022-11-11 00840050500187 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500187 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500187 OneScreen AMERICAN SCREENING, L.L.C. NFW 2022-11-11 00840050500187 OneScreen AMERICAN SCREENING, L.L.C. NFT 2022-11-11 00840050500194 OneScreen AMERICAN SCREENING, L.L.C. NFT 2022-11-11 00840050500194 OneScreen AMERICAN SCREENING, L.L.C. NFW 2022-11-11 00840050500194 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500194 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500200 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500200 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500200 OneScreen AMERICAN SCREENING, L.L.C. NFW 2022-11-11 00840050500200 OneScreen AMERICAN SCREENING, L.L.C. NFT 2022-11-11 00840050500217 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500217 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500217 OneScreen AMERICAN SCREENING, L.L.C. NFW 2022-11-11 00840050500217 OneScreen AMERICAN SCREENING, L.L.C. NFT 2022-11-11 00840050500224 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500224 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500224 OneScreen AMERICAN SCREENING, L.L.C. NFW 2022-11-11 00840050500224 OneScreen AMERICAN SCREENING, L.L.C. NFT 2022-11-11 00840050500231 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500231 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500231 OneScreen AMERICAN SCREENING, L.L.C. NFT 2022-11-11 00840050500231 OneScreen AMERICAN SCREENING, L.L.C. NFW 2022-11-11