FDA.report

CSI

Primary DI
00850798007688
Brand
CSI
Company
TRANSMED CO, LLC
Model
CSI-CUP-8105
Device description
CSI Cup - CLIA Screen In-Vitro 10 Panel Drug Test, Click Seal Cap, AMP, BUP, BZO, COC, MET, MDMA, MOP, MTD, OXY, THC, 25/BX
Published
2019-01-23
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
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications

CodeDeviceSpecialtyClass
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850798007671PackageGS124In Commercial Distribution
00850798007688PackageGS14In Commercial Distribution
00850798007664PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850798007671008507980076718507980076710850798007671
00850798007688008507980076888507980076880850798007688
00850798007664008507980076648507980076640850798007664

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
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 DIBrandModelCatalogPublished
00850798007787CSICSI-CUP-1145S2019-10-01
00850798007749REFREF-EWCUP-2642019-09-29
00850798007633CSI CSI-CUP-2652018-05-17
00850798007022CSICSI-CUP-11442017-02-08
00850798007039CSICSI-CUP-1144A32017-02-08
00850798007626CSI CSI-CUP-285T2017-09-21

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