SAFElife™

Primary DI
00816862027709
Brand
SAFElife™
Company
WONDFO USA CO., LTD.
Model
ND-61012N
Device description
10-Panel T-Cup; AMP500,BAR300,BZO300,COC150,MDMA500,MET500,MTD300,OPI2000,OXY100,THC50
Published
2025-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
PTGTest, Methadone, Over The Counter
PTHTest, Barbiturate, 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
PTGTest, Methadone, Over The CounterClinical Toxicology2
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
00816862027709PrimaryGS10
00816862027693Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816862027709008168620277098168620277090816862027709
00816862027693008168620276938168620276930816862027693

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
25
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
00840050500170OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500170OneScreenAMERICAN SCREENING, L.L.C.PTG2022-11-11
00840050500170OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500170OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500170OneScreenAMERICAN SCREENING, L.L.C.NFY2022-11-11
00840050500170OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500170OneScreenAMERICAN SCREENING, L.L.C.NFV2022-11-11
00840050500170OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.NFY2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.PTG2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.NFV2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.NFY2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.NFV2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.PTG2022-11-11
00840050500200OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500200OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500200OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500200OneScreenAMERICAN SCREENING, L.L.C.NFY2022-11-11
00840050500200OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500200OneScreenAMERICAN SCREENING, L.L.C.NFV2022-11-11