FDA.reportPublic FDA data

Prime Screen®

Primary DI
00810174471410
Brand
Prime Screen®
Company
WONDFO USA CO., LTD.
Model
DTDOA-274-1BX-A
Device description
Prime Screen® 7-Panel T-Cup;1 per box; AMP,BZO,COC,MET,OPI,OXY,THC
Published
2026-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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

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
00810174471410PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810174471410008101744714108101744714100810174471410

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.

Regulatory Flags#

DUNS number
849098897
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
00816862028010SAFElife™CDOA-L111452025-12-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00311917077932WalgreensWALGREEN CO.NGG2026-10-14
00311917077932WalgreensWALGREEN CO.NGL2026-10-14
00311917077932WalgreensWALGREEN CO.NFY2026-10-14
00311917077932WalgreensWALGREEN CO.NFW2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFW2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGG2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFV2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFY2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGL2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFT2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGL2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFY2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFT2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGG2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFW2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFV2026-10-14
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NGG2026-10-13
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NFY2026-10-13
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NFV2026-10-13
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NGL2026-10-13
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NFT2026-10-13
06942598249383One Step® Buprenorphine (BUP10) Home Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NGL2026-10-12
06942598249390One Step® Benzodiazepines (BZO300) Home Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NFV2026-10-12
06942598249406One Step® Methamphetamine (MET500) Home Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NGG2026-10-12
06942598249420One Step® Morphine (MOP/OPI2000) Home Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NGL2026-10-12
06936983113939Alltest MDMA500 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGG2026-04-21
06936983113946Alltest MET500 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGG2026-04-21
06936983113953Alltest MOP300 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983113977Alltest MOP2000 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983113984Alltest OXY100 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21