Home GUDID 00810174471045 PRIME SCREEN®
Primary DI 00810174471045
Brand PRIME SCREEN®
Company WONDFO USA CO., LTD.
Model DCDOA-254-1BX-A
Device description Prime Screen®; 5- Panel T-Cup Compact; AMP,COC,mAMP,OPI,THC
Published 2025-12-03
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true
Single use true Product Codes# Code, Name table Code Name NFT Test, Amphetamine, Over The Counter NFW Test, Cannabinoid, Over The Counter NFY Test, Cocaine And Cocaine Metabolites, Over The Counter NGG Test, Methamphetamine, Over The Counter NGL Test, Opiates, Over The Counter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class 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 NGG Test, Methamphetamine, 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 00810174471045 Primary GS1 0 00810174471038 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 00810174471045 00810174471045 810174471045 0810174471045 00810174471038 00810174471038 810174471038 0810174471038
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 25 Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840050500170 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500170 OneScreen AMERICAN SCREENING, L.L.C. NGG 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. NGG 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. NGG 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. NGG 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 00840050500217 OneScreen AMERICAN SCREENING, L.L.C. NGG 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 00840050500224 OneScreen AMERICAN SCREENING, L.L.C. NGG 2022-11-11
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