FDA.report

INSTANT-VIEW Cocaine (150) Urine Cassette Test

Primary DI
10796918000412
Brand
INSTANT-VIEW Cocaine (150) Urine Cassette Test
Company
ALFA SCIENTIFIC DESIGNS, INC.
Model
03-3054
Device description
INSTANT-VIEW Cocaine (150) Urine Cassette Test
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites

Product Code Classifications

CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10796918000412PrimaryGS10
00796918000415Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1079691800041210796918000412
00796918000415007969180004157969180004150796918000415

GMDN Terms

TermDefinition
Cocaine/cocaine metabolite 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 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. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods

Method

Regulatory Flags

DUNS number
176391167
Device count
25
DM exempt
true
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

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