FDA.report

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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
DJGEnzyme Immunoassay, Opiates

Product Code Classifications

CodeDeviceSpecialtyClass
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850798007640PackageGS125In Commercial Distribution
00850798007657PackageGS14In Commercial Distribution
00850798007633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850798007640008507980076408507980076400850798007640
00850798007657008507980076578507980076570850798007657
00850798007633008507980076338507980076330850798007633

GMDN Terms

TermDefinition
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of one or multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods

Method

Regulatory Flags

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

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10810173656037HealgenHealgen Scientific Limited Liability CompanyDJG2026-03-11
00850076346027HealgenHEALGEN LIFE SCIENCE, LLCDJG2026-02-06
10810173655627HealgenHealgen Scientific Limited Liability CompanyDJG2026-01-30
10810173655740HealgenHealgen Scientific Limited Liability CompanyDJG2026-01-30
00810173654814HealgenHealgen Scientific Limited Liability CompanyDJG2026-01-08
10810173652169HealgenHealgen Scientific Limited Liability CompanyDJG2025-12-19
10810173654132HealgenHealgen Scientific Limited Liability CompanyDJG2025-12-19
10810173654583Healgen Healgen Scientific Limited Liability CompanyDJG2025-12-19
00850624008643Fentanyl II Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.DJG2025-11-17
00850013037001Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDJG2025-10-31
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10815845024268SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.DJG2024-12-17
10815845024398SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.DJG2024-12-17
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00812101031032DRI Tramadol Cutoff Calibrator KitARK DIAGNOSTICS INCDJG2024-11-14
00812101031049DRI Tramadol Calibrator KitARK DIAGNOSTICS INCDJG2024-11-14
00812101031056DRI Tramadol Control KitARK DIAGNOSTICS INCDJG2024-11-14
00812101031063ARK™ Hydrocodone AssayARK DIAGNOSTICS INCDJG2024-10-16
00812101031070ARK™ Hydrocodone AssayARK DIAGNOSTICS INCDJG2024-10-16
00812101031087ARK™ Hydrocodone AssayARK DIAGNOSTICS INCDJG2024-10-16
00812101031094ARK™ Hydrocodone CalibratorARK DIAGNOSTICS INCDJG2024-10-16
00812101031100ARK™ Hydrocodone Calibrator NegativeARK DIAGNOSTICS INCDJG2024-10-16
00812101031117ARK™ Hydrocodone Calibrator CutoffARK DIAGNOSTICS INCDJG2024-10-16
00812101031124ARK™ Hydrocodone ControlARK DIAGNOSTICS INCDJG2024-10-16
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