FDA.reportPublic FDA data

CSI

Primary DI
00850798007633
Brand
CSI
Company
TRANSMED CO, LLC
Model
CSI-CUP-265
Device description
CSI Cup - CLIA Screen In-Vitro 6 Panel Drug Test, Click Seal Cap, AMP, BZO, COC, MET, MOP, THC, 25/BX
Published
2018-05-17
Public version status
Update
Distribution status
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
DJGEnzyme Immunoassay, Opiates
DKZEnzyme Immunoassay, Amphetamine
JXMEnzyme Immunoassay, Benzodiazepine
LAFGas Chromatography, Methamphetamine
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2
LAFGas Chromatography, MethamphetamineClinical Toxicology2
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850798007640PackageGS125In Commercial Distribution
00850798007657PackageGS14In Commercial Distribution
00850798007633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850798007640008507980076408507980076400850798007640
00850798007657008507980076578507980076570850798007657
00850798007633008507980076338507980076330850798007633

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
022637761
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
00850798007008CSICSI-CUP-11442017-02-08
00850798007602CSI CSI-CUP-285T2017-09-21
00850798007664CSI CSI-CUP-81052019-01-23
00850798007725REFREF-EWCUP-2642019-09-29
00850798007787CSICSI-CUP-1145S2019-10-01
00850798007039CSICSI-CUP-1144A32017-02-08
00850798007749REFREF-EWCUP-2642019-09-29
00850798007688CSI CSI-CUP-81052019-01-23
00850798007022CSICSI-CUP-11442017-02-08
00850798007626CSI CSI-CUP-285T2017-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850013035004Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCDKZ2026-10-30
10850013035004Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCDJG2026-10-30
10850013035004Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCJXM2026-10-30
10850013035004Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCDIO2026-10-30
10850013035004Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCLDJ2026-10-30
B115SCDCARD01THC501SnapCheckDx Multi-Drug Screen Test DipcardADVIN BIOTECH, INC.LDJ2026-10-30
06942598249376One Step® Fentanyl(FYL1) Urine Test PanelHangzhou AllTest Biotech Co., Ltd.DJG2026-10-12
00894175000091QMedix™Diagnostic Automation, Inc.DJG2026-09-30
00894175000091QMedix™Diagnostic Automation, Inc.LAF2026-09-30
00894175000091QMedix™Diagnostic Automation, Inc.LDJ2026-09-30
00894175000091QMedix™Diagnostic Automation, Inc.DIO2026-09-30
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyLAF2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyLAF2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
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 CompanyLAF2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28