Home GUDID 00816862026788 Prime Screen
Primary DI 00816862026788
Brand Prime Screen
Company WONDFO USA CO., LTD.
Model DTDOA-1144-1BX-A
Device description Prime Screen® 14-Panel T-Cup; 1 Test per box; AMP,BAR,BUP,BZO,COC,MDMA,MET,MTD,OPI,OXY,PCP,PPX,TCA,THC
Published 2025-07-03
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
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 QAW Test, Tricyclic Antidepressants, Over The Counter QBF Test, Propoxyphene, 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 QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology 2 QBF Test, Propoxyphene, Over The Counter Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10816862026785 Package GS1 4 In Commercial Distribution 00816862026788 Primary GS1 0 00816862026771 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 10816862026785 10816862026785 00816862026788 00816862026788 816862026788 0816862026788 00816862026771 00816862026771 816862026771 0816862026771
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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 4 Degrees Celsius 30 Degrees Celsius
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 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. QBF 2022-11-11 00840050500170 OneScreen AMERICAN SCREENING, L.L.C. QAW 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 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. NFV 2022-11-11 00840050500170 OneScreen AMERICAN SCREENING, L.L.C. NFT 2022-11-11 00840050500187 OneScreen AMERICAN SCREENING, L.L.C. PTG 2022-11-11 00840050500187 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. NFV 2022-11-11 00840050500187 OneScreen AMERICAN SCREENING, L.L.C. PTH 2022-11-11 00840050500187 OneScreen AMERICAN SCREENING, L.L.C. QAW 2022-11-11 00840050500187 OneScreen AMERICAN SCREENING, L.L.C. QBF 2022-11-11 00840050500194 OneScreen AMERICAN SCREENING, L.L.C. QAW 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. QBF 2022-11-11 00840050500194 OneScreen AMERICAN SCREENING, L.L.C. NFY 2022-11-11 00840050500194 OneScreen AMERICAN SCREENING, L.L.C. NFW 2022-11-11 00840050500194 OneScreen AMERICAN SCREENING, L.L.C. NFV 2022-11-11
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