FDA.reportPublic FDA data

PRIME SCREEN®

Primary DI
00810174470987
Brand
PRIME SCREEN®
Company
WONDFO USA CO., LTD.
Model
DTDOA-1144-10BX-A
Device description
14-Panel T-Cup 10 per Box; AMP,BAR,BUP,BZO,CO C,MET,MDMA,MTD,OPI,OXY,PCP,PPX,TCA,THC
Published
2025-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LCMEnzyme Immunoassay, Phencyclidine
NFTTest, Amphetamine, Over The Counter
NFVTest, Benzodiazepine, Over The Counter
NFWTest, Cannabinoid, Over The Counter
NFYTest, Cocaine And Cocaine Metabolites, Over The Counter
NGGTest, Methamphetamine, Over The Counter
NGLTest, Opiates, Over The Counter
PTGTest, Methadone, Over The Counter
PTHTest, Barbiturate, Over The Counter
QAWTest, Tricyclic Antidepressants, Over The Counter
QBFTest, Propoxyphene, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCMEnzyme Immunoassay, PhencyclidineUnknownU
NFTTest, Amphetamine, Over The CounterClinical Toxicology2
NFVTest, Benzodiazepine, Over The CounterClinical Toxicology2
NFWTest, Cannabinoid, Over The CounterClinical Toxicology2
NFYTest, Cocaine And Cocaine Metabolites, Over The CounterClinical Toxicology2
NGGTest, Methamphetamine, Over The CounterClinical Toxicology2
NGLTest, Opiates, Over The CounterClinical Toxicology2
PTGTest, Methadone, Over The CounterClinical Toxicology2
PTHTest, Barbiturate, Over The CounterClinical Toxicology2
QAWTest, Tricyclic Antidepressants, Over The CounterClinical Toxicology2
QBFTest, Propoxyphene, Over The CounterClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182701000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182701000Wondfo T-Cup Multi-Drug Urine Test CupGuangzhou Wondfo Biotech Co., Ltd.2018-12-03NFT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810174470987PrimaryGS10
00810174470970Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810174470987008101744709878101744709870810174470987
00810174470970008101744709708101744709700810174470970

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, rapid ICT, clinicalA 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.

Contacts#

Phone, Email table
PhoneEmail
630-468-2199wondfo@wondfousa.com

Regulatory Flags#

DUNS number
849098897
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810174470369HORMONElife™DW52-S-SQ-6BX-H2026-06-26
00810174470543HORMONElife™DW1-S25-15BX-H2026-06-26
00810174471229Prime Screen®DCDOA-L964-5BX-A2026-06-26
00810174471410Prime Screen®DTDOA-274-1BX-A2026-06-26
00816862027303WELLlife™WCOV-CON-52026-06-01
00816862028416WELLlife™WCOVID-POC-252026-06-01
00816862028294SAFElife™CDOA-L11135A32026-05-15
00816862028324WELLlife™ WFOB-OTC-2BX2026-05-15
00816862028348SAFElife™CDOA-6135F2026-05-15
00816862028362SAFElife™TDOA-6135F2026-05-15
00816862028393SAFElife™WEDDP-1142026-05-15
00816862028249SAFElife™CDOA-12135NT2026-01-15
00816862028270HORMONElife™H1-S-20BG2026-01-15
00816862027723HORMONElife™H1-S-E10-25BX-CLIA2026-01-15
00816862028164SAFElife™CDOA-12135NT2026-01-15
00816862028263HORMONElife™H1-S-20BG2026-01-15
00816862028027SAFElife™CDOA-L111452025-12-15
00816862028089SAFElife™CDOA-L11135A32025-12-15
00816862028102HORMONElife™H2-S-50BG2025-12-15
00816862028157HORMONElife™H1-C-25BX-CLIA2025-12-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850076289706HYSEN Multiple Drugs Test CupHYSEN INC.NFV2026-07-20
00850076289706HYSEN Multiple Drugs Test CupHYSEN INC.NFW2026-07-20
00850076289706HYSEN Multiple Drugs Test CupHYSEN INC.NFY2026-07-20
00850076289706HYSEN Multiple Drugs Test CupHYSEN INC.NGL2026-07-20
00850076289706HYSEN Multiple Drugs Test CupHYSEN INC.PTG2026-07-20
00850076289706HYSEN Multiple Drugs Test CupHYSEN INC.PTH2026-07-20
00850076289706HYSEN Multiple Drugs Test CupHYSEN INC.NFT2026-07-20
00850076289713HYSEN Multiple Drugs Test CupHYSEN INC.NFW2026-07-20
00850076289713HYSEN Multiple Drugs Test CupHYSEN INC.PTH2026-07-20
00850076289713HYSEN Multiple Drugs Test CupHYSEN INC.PTG2026-07-20
00850076289713HYSEN Multiple Drugs Test CupHYSEN INC.NGL2026-07-20
00850076289713HYSEN Multiple Drugs Test CupHYSEN INC.NGG2026-07-20
00850076289713HYSEN Multiple Drugs Test CupHYSEN INC.NFY2026-07-20
00850076289713HYSEN Multiple Drugs Test CupHYSEN INC.NFV2026-07-20
00850076289713HYSEN Multiple Drugs Test CupHYSEN INC.NFT2026-07-20
G474M2105010mLife Rapid Drug TestMlife Diagnostics, LLCNFW2026-07-20
G474M2105010mLife Rapid Drug TestMlife Diagnostics, LLCNFT2026-07-20
G474M2105010mLife Rapid Drug TestMlife Diagnostics, LLCNFY2026-07-20
G474M2105010mLife Rapid Drug TestMlife Diagnostics, LLCNGG2026-07-20
G474M2105010mLife Rapid Drug TestMlife Diagnostics, LLCNGL2026-07-20
G474M2107010mLife Rapid Drug TestMlife Diagnostics, LLCNFW2026-07-20
G474M2107010mLife Rapid Drug TestMlife Diagnostics, LLCNGL2026-07-20
G474M2107010mLife Rapid Drug TestMlife Diagnostics, LLCNGG2026-07-20
G474M2107010mLife Rapid Drug TestMlife Diagnostics, LLCNFY2026-07-20
G474M2107010mLife Rapid Drug TestMlife Diagnostics, LLCNFT2026-07-20
G474M2113010mLife Rapid Drug TestMlife Diagnostics, LLCNFW2026-07-20
G474M2113010mLife Rapid Drug TestMlife Diagnostics, LLCNGG2026-07-20
G474M2113010mLife Rapid Drug TestMlife Diagnostics, LLCNGL2026-07-20
G474M2113010mLife Rapid Drug TestMlife Diagnostics, LLCNFY2026-07-20
G474M2113010mLife Rapid Drug TestMlife Diagnostics, LLCNFV2026-07-20