FDA.reportPublic FDA data

co-innovation

Primary DI
16970429841816
Brand
co-innovation
Company
Co-Innovation Biotech Co., Ltd
Model
Rapid Multi-drug Test
Device description
Rapid Multi-drug Test Cup
Published
2022-11-11
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
JXMEnzyme Immunoassay, Benzodiazepine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXMEnzyme Immunoassay, BenzodiazepineClinical 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
16970429841816PackageGS125Not in Commercial Distribution
26970429841813PackageGS1100Not in Commercial Distribution
36970429841810PackageGS1210Not in Commercial Distribution
06970429841819PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697042984181616970429841816
2697042984181326970429841813
3697042984181036970429841810
06970429841819069704298418196970429841819

GMDN Terms#

Term, Definition table
TermDefinition
Cocaine/cocaine metabolite 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 cocaine and/or cocaine metabolites 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421302978
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
00810173656726HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656702AccurateHealgen Scientific Limited Liability CompanyJXM2026-06-02
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035554Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035691Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035707Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10694644300793RDSAMERICAN BIO MEDICA CORPORATIONJXM2021-07-22
10694644300786RDSAMERICAN BIO MEDICA CORPORATIONJXM2021-06-10
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONJXM2021-05-28
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.JXM2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.JXM2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.JXM2020-06-18
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONJXM2020-05-29
10694644200505RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONJXM2019-10-03
10694644200499RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONJXM2019-09-28
10694644300762RDSAMERICAN BIO MEDICA CORPORATIONJXM2019-02-13
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONJXM2019-02-12