FDA.reportPublic FDA data

SAFElife™

Primary DI
10816862027348
Brand
SAFElife™
Company
WONDFO USA CO., LTD.
Model
CDOA-1085NT
Device description
SAFElife 8-Panel T-Cup Compact without THC; AMP,BAR,BUP,BZO,COC,mAMP,MTD,OPI
Published
2025-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NFTTest, Amphetamine, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFTTest, Amphetamine, 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
10816862027348PackageGS14In Commercial Distribution
00816862027341PrimaryGS10
00816862027334Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081686202734810816862027348
00816862027341008168620273418168620273410816862027341
00816862027334008168620273348168620273340816862027334

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
849098897
Device count
25
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
00840050500170OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500200OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500217OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500224OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500231OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500248OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500255OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500262OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500279OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500286OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500293OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500309OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500316OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500323OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500330OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500347OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500354OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500361OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500378OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500385OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500392OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500408OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500415OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500422OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500439OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500446OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500453OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500460OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11