FDA.reportPublic FDA data

Wondfo

Primary DI
00816862022995
Brand
Wondfo
Company
WONDFO USA CO., LTD.
Model
W53-S-25BX
Catalog number
W53-S-25BX
Device description
25-Strips; Alcohol Saliva Test Box 25 Pcs
Published
2021-08-20
Public version status
Update
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
DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme MethodClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816862022992PackageGS1168In Commercial Distribution
00816862022995PrimaryGS10
00816862023008Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081686202299210816862022992
00816862022995008168620229958168620229950816862022995
00816862023008008168620230088168620230080816862023008

GMDN Terms#

Term, Definition table
TermDefinition
Ethanol (ETOH) IVD, kit, rapid colorimetric, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of ethyl alcohol (ETOH) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses to assess for alcohol intoxication and in the management of alcoholism. 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
25
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00816862028072SAFElife™CDOA-L11135A32025-12-15
00816862028096HORMONElife™H2-S-50BG2025-12-15
00816862028119HORMONElife™H1-C-25BX-CLIA2025-12-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414654089Atellica CH Ethanol (EtohC)Siemens Healthcare Diagnostics Inc.DIC2025-10-15
00816862024531WondfoWONDFO USA CO., LTD.DIC2024-05-23
10816862024538WondfoWONDFO USA CO., LTD.DIC2024-05-23
10673486000993TECO DIAGNOSTICSTECO DIAGNOSTICSDIC2022-09-07
06970429841444co-innovationCo-Innovation Biotech Co., LtdDIC2022-01-15
06970429841536co-innovationCo-Innovation Biotech Co., LtdDIC2022-01-15
06970429841628co-innovationCo-Innovation Biotech Co., LtdDIC2022-01-15
06970429841703co-innovationCo-Innovation Biotech Co., LtdDIC2022-01-15
06970429841802co-innovationCo-Innovation Biotech Co., LtdDIC2022-01-15
06970429841901co-innovationCo-Innovation Biotech Co., LtdDIC2022-01-15
00816862023015WondfoWONDFO USA CO., LTD.DIC2021-08-20
10816862022992WondfoWONDFO USA CO., LTD.DIC2021-08-20
10816862023012WondfoWONDFO USA CO., LTD.DIC2021-08-20
06970429841611co-innovationCo-Innovation Biotech Co., LtdDIC2021-03-29
00811727017390Pointe Ethyl Alcohol Reagent SetHORIBA INSTRUMENTS INCORPORATEDDIC2020-09-25
00811727017406Pointe Ethyl Alcohol Reagent SetHORIBA INSTRUMENTS INCORPORATEDDIC2020-09-25
07613336121221Ethanol Gen.2Roche Diagnostics GmbHDIC2020-03-05
07613336157817Ethanol Gen.2Roche Diagnostics GmbHDIC2020-03-05
00816862022339WondfoWONDFO USA CO., LTD.DIC2020-02-20
10816862022336WondfoWONDFO USA CO., LTD.DIC2020-02-20
B2984090010AlcoCheckExpress Diagnostic Int'l, Inc.DIC2019-05-02
06970429841284co-innovationCo-Innovation Biotech Co., LtdDIC2019-03-22
26970429841288co-innovationCo-Innovation Biotech Co., LtdDIC2019-03-22
00628063401086Ethanol AssaySEKISUI DIAGNOSTICS, LLCDIC2018-11-28
00840937110355ImmunalysisIMMUNALYSIS CORPDIC2017-09-07
00840937110362ImmunalysisIMMUNALYSIS CORPDIC2017-09-07
00840937110379ImmunalysisIMMUNALYSIS CORPDIC2017-09-07
00840937110386ImmunalysisIMMUNALYSIS CORPDIC2017-09-07
00817830022825MP Saliva Alcohol Test StripRAPID DIAGNOSTICS INCDIC2017-08-03
B298409000AlcoCheckEXPRESS DIAGNOSTICS INT'L, INC.DIC2017-02-20