FDA.reportPublic FDA data

DTPM

Primary DI
06970429841635
Brand
DTPM
Company
Co-Innovation Biotech Co., Ltd
Model
16P
Published
2023-12-08
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DISEnzyme Immunoassay, Barbiturate
DJCThin Layer Chromatography, Methamphetamine
DJGEnzyme Immunoassay, Opiates
DJREnzyme Immunoassay, Methadone
DKZEnzyme Immunoassay, Amphetamine
DNKThin Layer Chromatography, Morphine
JXMEnzyme Immunoassay, Benzodiazepine
LFGRadioimmunoassay, Tricyclic Antidepressant Drugs
LFJCatheter, Subclavian

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DISEnzyme Immunoassay, BarbiturateClinical Toxicology2
DJCThin Layer Chromatography, MethamphetamineClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DJREnzyme Immunoassay, MethadoneClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
DNKThin Layer Chromatography, MorphineClinical Toxicology2
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2
LFGRadioimmunoassay, Tricyclic Antidepressant DrugsClinical Toxicology2
LFJCatheter, SubclavianGastroenterology, Urology2

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
16970429841632PackageGS125Not in Commercial Distribution
26970429841639PackageGS1100Not in Commercial Distribution
36970429841636PackageGS1210Not in Commercial Distribution
06970429841635PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697042984163216970429841632
2697042984163926970429841639
3697042984163636970429841636
06970429841635069704298416356970429841635

GMDN Terms#

Term, Definition table
TermDefinition
Barbiturate 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 barbiturates 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.

Regulatory Flags#

DUNS number
421302978
Device count
1
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
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
16970429840178co-innovationHCG TEST2023-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00894175000091QMedix™Diagnostic Automation, Inc.DJG2026-09-30
00894175000091QMedix™Diagnostic Automation, Inc.DIO2026-09-30
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDIS2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyLFG2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDJR2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDJR2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyLFG2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDIS2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyLFG2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyDJR2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyDIS2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyDIS2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyLFG2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyDJR2026-09-28