FDA.reportPublic FDA data

PRIME SCREEN®

Primary DI
00810174470970
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
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PTHTest, Barbiturate, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTHTest, Barbiturate, 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
849098897
Device count
10
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
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.PTH2026-07-20
00850076289713HYSEN Multiple Drugs Test CupHYSEN INC.PTH2026-07-20
G474M2113010mLife Rapid Drug TestMlife Diagnostics, LLCPTH2026-07-20
G474M2116010mLife Rapid Drug TestMlife Diagnostics, LLCPTH2026-07-20
G474M2117010mLife Rapid Drug TestMlife Diagnostics, LLCPTH2026-07-20
10722066018009Rapid ResponseBTNX IncPTH2026-07-14
10722066015053Rapid ResponseBTNX IncPTH2026-05-15
10722066015084Rapid ResponseBTNX IncPTH2026-05-15
00816862028294SAFElife™WONDFO USA CO., LTD.PTH2026-05-15
00816862028348SAFElife™WONDFO USA CO., LTD.PTH2026-05-15
00816862028362SAFElife™WONDFO USA CO., LTD.PTH2026-05-15
16936983131633Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.PTH2026-04-16
16936983131640Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.PTH2026-04-16
16936983131657Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.PTH2026-04-16
16936983131664Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.PTH2026-04-16
16936983131671Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.PTH2026-04-16
16936983131695Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.PTH2026-04-16
16936983138632Multi-Drug 12 Drugs Rapid Test Cup Hangzhou AllTest Biotech Co., Ltd.PTH2026-04-16
16936983141120Discover Multi-Drug 12 Drugs Rapid Test Cup Hangzhou AllTest Biotech Co., Ltd.PTH2026-04-16
16936983141137Discover Multi-Drug 12 Drugs Rapid Test Cup Hangzhou AllTest Biotech Co., Ltd.PTH2026-04-16
16936983144688Discover Multi-Drug 10 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.PTH2026-04-16
16936983148846Discover Multi-Drug 12 Drugs Rapid Test Cup (Urine) Hangzhou AllTest Biotech Co., Ltd.PTH2026-04-16
16936983153819Discover Multi-Drug 13 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.PTH2026-04-15
16936983169599Alltest Multi-Drug Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.PTH2026-04-15
16936983169605Alltest Multi-Drug Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.PTH2026-04-15
16936983170007Alltest Multi-Drug 12 Drugs Urine Test PanelHangzhou AllTest Biotech Co., Ltd.PTH2026-04-15
16936983170014Alltest Multi-Drug 13 Drugs Urine Test PanelHangzhou AllTest Biotech Co., Ltd.PTH2026-04-15
16936983170021Alltest Multi-Drug 14 Drugs Urine Test PanelHangzhou AllTest Biotech Co., Ltd.PTH2026-04-15
16936983170038Alltest Multi-Drug 14 Drugs Urine Test PanelHangzhou AllTest Biotech Co., Ltd.PTH2026-04-15
16936983171998Alltest Multi-Drug 13 Drugs Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.PTH2026-04-15