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
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
00816862028010SAFElife™CDOA-L111452025-12-15
00816862028072SAFElife™CDOA-L11135A32025-12-15
00816862028096HORMONElife™H2-S-50BG2025-12-15
00816862028119HORMONElife™H1-C-25BX-CLIA2025-12-15
10810174471059HORMONElife™DWS-H10L20-H2025-12-05
10810174471073HORMONElife™DWS-H15L40-H2025-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10648564316280SnapCheckDx Rapid Urine THC TestHangzhou Aichek Medical Technology Co., Ltd.NFW2026-05-12
10197344170203MEDLINEMEDLINE INDUSTRIES, INC.NFT2026-01-29
10197344170210MEDLINEMEDLINE INDUSTRIES, INC.NFT2026-01-23
10304040186739Henry ScheinHENRY SCHEIN, INC.NFT2024-12-10
10304040186746Henry ScheinHENRY SCHEIN, INC.NFT2024-12-10
10694644300793RDSAMERICAN BIO MEDICA CORPORATIONLCM2021-07-22
10694644300786RDSAMERICAN BIO MEDICA CORPORATIONLCM2021-06-10
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONLCM2021-05-28
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LCM2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LCM2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.LCM2020-06-18
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONLCM2020-05-29
10694644200505RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLCM2019-10-03
10694644200499RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLCM2019-09-28
10694644300762RDSAMERICAN BIO MEDICA CORPORATIONLCM2019-02-13
10694644300755RDSAMERICAN BIO MEDICA CORPORATIONLCM2018-09-14
10694644300748RDSAMERICAN BIO MEDICA CORPORATIONLCM2018-07-05
10694644200482RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLCM2018-05-23
10694644300731RDSAMERICAN BIO MEDICA CORPORATIONLCM2018-05-23
10694644200475RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLCM2018-04-19
10694644300724RDSAMERICAN BIO MEDICA CORPORATIONLCM2018-04-19
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONLCM2018-03-30
10694644300694RDSAMERICAN BIO MEDICA CORPORATIONLCM2018-03-23
10694644300700RDSAMERICAN BIO MEDICA CORPORATIONLCM2018-03-23