FDA.reportPublic FDA data

Prime Screen

Primary DI
00816862025996
Brand
Prime Screen
Company
WONDFO USA CO., LTD.
Model
DWDCO-114-10BX-A
Device description
Prime Screen® 1-Panel Card; 10 per box; COC Cocaine
Published
2024-12-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NFYTest, Cocaine And Cocaine Metabolites, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFYTest, Cocaine And Cocaine Metabolites, Over The CounterClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202567000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202567000Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel RxGuangzhou Wondfo Biotech Co., Ltd.2020-09-25NFT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816862025993PackageGS1100In Commercial Distribution
00816862025996PrimaryGS10
00816862025989Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081686202599310816862025993
00816862025996008168620259968168620259960816862025996
00816862025989008168620259898168620259890816862025989

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius30 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
849098897
Device count
10
DM exempt
true
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
00311917077932WalgreensWALGREEN CO.NFY2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFY2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFY2026-10-14
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NFY2026-10-13
10722066005511Rapid ResponseBTNX IncNFY2026-10-09
10722066018979Rapid ResponseBTNX IncNFY2026-10-08
10722066019013Rapid ResponseBTNX IncNFY2026-10-08
10722066019020Rapid ResponseBTNX IncNFY2026-10-08
10722066019037Rapid ResponseBTNX IncNFY2026-10-08
10722066019044Rapid ResponseBTNX IncNFY2026-10-08
10722066018955Rapid ResponseBTNX IncNFY2026-10-06
10722066018696Rapid ResponseBTNX IncNFY2026-09-18
G474M210501EI0mLife Rapid Drug TestMlife Diagnostics, LLCNFY2026-08-14
06936983114066Alltest COC150 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NFY2026-04-21
06936983114318Alltest COC150 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFY2026-04-21
06936983114394Alltest COC150 Rapid Test Panel (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFY2026-04-21
06936983114554Alltest COC150 Home Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NFY2026-04-21
06936983114707Alltest COC150 Home Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFY2026-04-21
06936983113915Alltest COC150 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFY2026-04-17
16936983131633Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFY2026-04-16
16936983131640Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFY2026-04-16
16936983138632Multi-Drug 12 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NFY2026-04-16
16936983141120Discover Multi-Drug 12 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NFY2026-04-16
16936983141137Discover Multi-Drug 12 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NFY2026-04-16
16936983144688Discover Multi-Drug 10 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFY2026-04-16
06936983114790Alltest Multi-Drug 15 Drugs Rapid Test Panel (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFY2026-04-16
06936983114806Alltest Multi-Drug 15 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFY2026-04-16
06936983114813Alltest Multi-Drug 15 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFY2026-04-16
06936983114820Alltest Multi-Drug 12 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFY2026-04-16
06936983114837Alltest Multi-Drug 12 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFY2026-04-16