Home GUDID 00816862028362 SAFElife™
Primary DI 00816862028362
Brand SAFElife™
Company WONDFO USA CO., LTD.
Model TDOA-6135F
Device description 13-Panel T-Cup; AMP1000,BAR300,BUP10,BZO300,COC300,MDMA500,MET1000,MOP300,MTD300,OXY100,PCP25,THC50,FTY1
Published 2026-05-15
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name LCM Enzyme Immunoassay, Phencyclidine NFT Test, Amphetamine, Over The Counter NFV Test, Benzodiazepine, 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 PTG Test, Methadone, Over The Counter PTH Test, Barbiturate, 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 NFV Test, Benzodiazepine, 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 PTG Test, Methadone, Over The Counter Clinical Toxicology 2 PTH Test, Barbiturate, Over The Counter Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816862028362 Primary GS1 0 00816862028355 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 00816862028362 00816862028362 816862028362 0816862028362 00816862028355 00816862028355 816862028355 0816862028355
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 G474M210501EI0 mLife Rapid Drug Test Mlife Diagnostics, LLC NGL 2026-08-14 G474M210501EI0 mLife Rapid Drug Test Mlife Diagnostics, LLC NGG 2026-08-14 G474M210501EI0 mLife Rapid Drug Test Mlife Diagnostics, LLC NFY 2026-08-14 G474M210501EI0 mLife Rapid Drug Test Mlife Diagnostics, LLC NFT 2026-08-14 G474M210501EI0 mLife Rapid Drug Test Mlife Diagnostics, LLC NFW 2026-08-14 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. NFY 2022-11-11 00840050500170 OneScreen AMERICAN SCREENING, L.L.C. NFT 2022-11-11 00840050500170 OneScreen AMERICAN SCREENING, L.L.C. NFV 2022-11-11 00840050500170 OneScreen AMERICAN SCREENING, L.L.C. NFW 2022-11-11 00840050500170 OneScreen AMERICAN SCREENING, L.L.C. NGG 2022-11-11 00840050500170 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500170 OneScreen AMERICAN SCREENING, L.L.C. PTH 2022-11-11 00840050500170 OneScreen AMERICAN SCREENING, L.L.C. PTG 2022-11-11 00840050500187 OneScreen AMERICAN SCREENING, L.L.C. NGG 2022-11-11 00840050500187 OneScreen AMERICAN SCREENING, L.L.C. NFT 2022-11-11 00840050500187 OneScreen AMERICAN SCREENING, L.L.C. NFV 2022-11-11 00840050500187 OneScreen AMERICAN SCREENING, L.L.C. NFW 2022-11-11 00840050500187 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500187 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500187 OneScreen AMERICAN SCREENING, L.L.C. PTG 2022-11-11 00840050500187 OneScreen AMERICAN SCREENING, L.L.C. PTH 2022-11-11 00840050500194 OneScreen AMERICAN SCREENING, L.L.C. NFT 2022-11-11 00840050500194 OneScreen AMERICAN SCREENING, L.L.C. NFV 2022-11-11 00840050500194 OneScreen AMERICAN SCREENING, L.L.C. NFW 2022-11-11 00840050500194 OneScreen AMERICAN SCREENING, L.L.C. PTH 2022-11-11 00840050500194 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500194 OneScreen AMERICAN SCREENING, L.L.C. NGG 2022-11-11 00840050500194 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11