FDA.reportPublic FDA data

co-innovation

Primary DI
16970429841809
Brand
co-innovation
Company
Co-Innovation Biotech Co., Ltd
Model
18P Drug Test
Device description
18P Drug Test
Published
2022-01-15
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DKZEnzyme Immunoassay, Amphetamine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153050000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153050000Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardCo-Innovation Biotech Co., Ltd.2016-04-26DJG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16970429841809PackageGS125Not in Commercial Distribution
26970429841806PackageGS1100Not in Commercial Distribution
36970429841803PackageGS1210Not in Commercial Distribution
06970429841802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697042984180916970429841809
2697042984180626970429841806
3697042984180336970429841803
06970429841802069704298418026970429841802

GMDN Terms#

Term, Definition table
TermDefinition
Methaqualone IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of methaqualone in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421302978
Device count
1
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
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
00810173656702AccurateHealgen Scientific Limited Liability CompanyDKZ2026-06-02
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035691Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10722066005290Rapid Response Multi-Drug Integrated Split Spec. CupBTNX IncDKZ2023-04-28
10694644400745INCUPAMERICAN BIO MEDICA CORPORATIONDKZ2021-06-24
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONDKZ2021-05-28
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10694644200505RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKZ2019-10-03
10694644200499RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKZ2019-09-28
10694644400714INCUPAMERICAN BIO MEDICA CORPORATIONDKZ2019-03-11
10694644500407RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDKZ2018-12-05
10694644400707INCUPAMERICAN BIO MEDICA CORPORATIONDKZ2018-10-29
10694644500391RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDKZ2018-06-20
10694644200482RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKZ2018-05-23
10722355002573Detector Drug CupImmunostics Company, IncDKZ2018-05-21
10722355002580Detector Drug CupImmunostics Company, IncDKZ2018-05-21
10694644400691INCUPAMERICAN BIO MEDICA CORPORATIONDKZ2018-04-20
10694644200475RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKZ2018-04-19
10694644300724RDSAMERICAN BIO MEDICA CORPORATIONDKZ2018-04-19
10694644300700RDSAMERICAN BIO MEDICA CORPORATIONDKZ2018-03-23
10694644300717RDSAMERICAN BIO MEDICA CORPORATIONDKZ2018-03-23