FDA.reportPublic FDA data

Immunalysis

Primary DI
00840937110386
Brand
Immunalysis
Company
IMMUNALYSIS CORP
Model
504-0060W
Catalog number
504-0060W
Device description
Ethyl Alcohol Enzyme Assay
Published
2017-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181553000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181553000Immunalysis Ethyl Alcohol Enzyme AssayImmunalysis Corporation2018-10-31DIC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840937110386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840937110386008409371103868409371103860840937110386

GMDN Terms#

Term, Definition table
TermDefinition
Ethyl glucuronide (EtG) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of ethyl glucuronide (EtG), a metabolite of ethanol alcohol (ETOH), in a clinical specimen using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002804244
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840937114636Immunalysis10063-1510063-152024-04-19
00840937114643Immunalysis10064-1510064-152024-04-19
00840937114650Immunalysis10065-1510065-152024-04-19
00840937114667Immunalysis10066-1510066-152024-04-19
00840937114674Immunalysis3020-153020-152024-04-19
00840937114568Immunalysis10068-1510068-152024-04-08
00840937114605ImmunalysisNegOFLP-0100NegOFLP-01002024-04-08
00840937103265Immunalysis10047-1010047-102023-10-26
00840937103272Immunalysis10048-1010048-102023-10-26
00840937103289Immunalysis10049-1010049-102023-10-26
00840937103296Immunalysis10050-1010050-102023-10-26
00840937112076Immunalysis3017-103017-102021-02-05
00840937112083Immunalysis10054-1010054-102021-02-05
00840937112090Immunalysis10053-1010053-102021-02-05
00840937112106Immunalysis10052-1010052-102021-02-05
00840937112113Immunalysis10051-1010051-102021-02-05
00840937111895Immunalysis10055-1010055-102020-03-31
00840937111918Immunalysis10056-1010056-102020-03-31
00840937111925Immunalysis10057-1010057-102020-03-31
00840937111932Immunalysis10058-1010058-102020-03-31

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
00816862022995WondfoWONDFO USA CO., LTD.DIC2021-08-20
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
00817830022825MP Saliva Alcohol Test StripRAPID DIAGNOSTICS INCDIC2017-08-03
B298409000AlcoCheckEXPRESS DIAGNOSTICS INT'L, INC.DIC2017-02-20