FDA.reportPublic FDA data

co-innovation

Primary DI
06970429840638
Brand
co-innovation
Company
Co-Innovation Biotech Co., Ltd
Model
ETG-Dipcard
Device description
Rapid ETG Test Dipcard
Published
2018-11-19
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DJZDevices, Breath Trapping, Alcohol

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJZDevices, Breath Trapping, AlcoholClinical Toxicology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16970429840635PackageGS1100Not in Commercial Distribution
36970429840639PackageGS120Not in Commercial Distribution
06970429840638PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697042984063516970429840635
3697042984063936970429840639
06970429840638069704298406386970429840638

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.

Regulatory Flags#

DUNS number
421302978
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970429840171co-innovationHCG TEST2023-04-28
06970429840195Flo12026-03-31
06970429844124Flo12026-03-31
06970429844117co-innovationLH TEST2025-10-20
06970429843417co-innovationCOT TEST2025-05-19
16970429843414co-innovationCOT TEST2025-05-19
06970429843318co-innovationFYL TEST2024-08-20
16970429843315co-innovationFYL TEST2024-08-20
06970429841345DTPM13P2023-12-08
06970429841635DTPM16P2023-12-08
16970429841342DTPM13P2023-12-08
16970429841632DTPM16P2023-12-08
06970429840102Co-innovationHCG Strip/4.0mm2017-03-23
06970429840119MomMedHCG TEST STRIP 2018-12-31
06970429840126AICAREHCG Pregnancy Test2019-03-18
06970429840133HealthyWiserHCG Test Strip2016-10-31
06970429840157HCG TEST STRIPHCG3.52019-12-25
06970429840164PREGABLE12021-06-02
06970429840300Co-innovationHCG Cassette2017-03-23
16970429840154HCG TEST STRIPHCG3.52019-12-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B90112SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2025-08-19
B90110SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2023-09-23
B90111SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2023-09-23
G354AAB08201AlcoBreath TubeAlcopro Inc.DJZ2022-09-22
G354AAB08402AlcoBreath TubeAlcopro Inc.DJZ2022-09-22
G354AAB15201AlcoBreath TubeAlcopro Inc.DJZ2022-09-22
G354AAB15402AlcoBreath TubeAlcopro Inc.DJZ2022-09-22
G354CCP024103CheckpointAlcopro Inc.DJZ2022-09-22
G354CCP042001CheckpointAlcopro Inc.DJZ2022-09-22
G354CCP044103CheckpointAlcopro Inc.DJZ2022-09-22
G354CCP082001CheckpointAlcopro Inc.DJZ2022-09-22
G354CCP084103CheckpointAlcopro Inc.DJZ2022-09-22
G354AAB08202AlcoBreath TubeAlcopro Inc.DJZ2022-09-22
G354AAB08400AlcoBreath TubeAlcopro Inc.DJZ2022-09-22
G354AAB15202AlcoBreath TubeAlcopro Inc.DJZ2022-09-22
G354AAB15400AlcoBreath TubeAlcopro Inc.DJZ2022-09-22
G354CCP022001CheckpointAlcopro Inc.DJZ2022-09-22
G354CCP024100CheckpointAlcopro Inc.DJZ2022-09-22
G354CCP042002CheckpointAlcopro Inc.DJZ2022-09-22
G354CCP044104CheckpointAlcopro Inc.DJZ2022-09-22
G354CCP082002CheckpointAlcopro Inc.DJZ2022-09-22
G354CCP084104CheckpointAlcopro Inc.DJZ2022-09-22
B90108SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2022-06-23
B90109SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2022-06-23
B90106SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2021-12-08
B90107SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2021-12-08
00853464001126AlcoMate CoreAK Globaltech CorpDJZ2021-06-21
B90101SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2021-04-07
B90102SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2021-04-07
B90103SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2021-04-07