FDA.reportPublic FDA data

AlereTM iCassette®

Primary DI
10858945006659
Brand
AlereTM iCassette®
Company
Instant Technologies, Inc.
Model
I-DCO-102
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858945006659PrimaryGS10
00858945006652Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085894500665910858945006659
00858945006652008589450066528589450066520858945006652

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-340-4029Qa.Portsmouth@abbott.com

Regulatory Flags#

DUNS number
019410187
Device count
25
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817405024025iCassetteABTDFYW11201AABTDFYW11201A2023-11-30
00817405021154UScreen®USSCup-10MUSSCup-10M2021-01-13
00817405021192UScreen®USSCupA-12CLIAUSSCUPA-12CLIA2021-01-13
00817405021222UScreen®USSCup-10MMO300USSCup-10MMO3002021-01-13
10817405021304iScreen™IS1 MET-DX2 IS1 MET-DX2 2020-08-21
10817405021311iScreen™IS12-DX2 IS12-DX2 2020-08-21
10817405021328iScreen™IS12BUP-DX2 IS12BUP-DX2 2020-08-21
10817405021373UScreen®USSCupA-11CLIALCUSSCupA-11CLIALC2021-05-25
00817405022229iScreen™ABTDUAW110704DABTDUAW110704D2022-06-16
00817405023240iScreen™ABTDUAW112701AABTDUAW112701A2022-11-09
00817405023257iScreen™ABTDUAW16701AABTDUAW16701A2022-11-09
00817405023264iScreen™ABTDUAW17701AABTDUAW17701A2022-11-09
00817405023271iScreen™ABTDUAW110701AABTDUAW110701A2022-11-09
00817405023288iScreen™ABTDUAW110702BABTDUAW110702B2022-11-09
00817405023295iScreen™ABTDUAW15701AABTDUAW15701A2022-11-09
00817405023301iScreen™ABTDUAW113701AABTDUAW113701A2023-02-10
00817405023318iScreen™ABTDOAW14701AABTDOAW14701A2022-11-09
00817405023325iScreen™ABTDUAW17702BABTDUAW17702B2022-11-09
00817405023332iScreen™ABTDOAW17701AABTDOAW17701A2022-11-09
00817405023349iScreen™ABTDUAW110703CABTDUAW110703C2022-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10694644300793RDSAMERICAN BIO MEDICA CORPORATIONDIO2021-07-22
10694644300786RDSAMERICAN BIO MEDICA CORPORATIONDIO2021-06-10
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONDIO2021-05-28
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2020-05-29
10694644200505RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDIO2019-10-03
10694644200499RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDIO2019-09-28
10694644300762RDSAMERICAN BIO MEDICA CORPORATIONDIO2019-02-13
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2019-02-12
10694644300755RDSAMERICAN BIO MEDICA CORPORATIONDIO2018-09-14
10694644300748RDSAMERICAN BIO MEDICA CORPORATIONDIO2018-07-05
10694644200482RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDIO2018-05-23
10694644300731RDSAMERICAN BIO MEDICA CORPORATIONDIO2018-05-23
10694644200475RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDIO2018-04-19
10694644300724RDSAMERICAN BIO MEDICA CORPORATIONDIO2018-04-19
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2018-03-30
10694644300694RDSAMERICAN BIO MEDICA CORPORATIONDIO2018-03-23
10694644300700RDSAMERICAN BIO MEDICA CORPORATIONDIO2018-03-23
10694644300717RDSAMERICAN BIO MEDICA CORPORATIONDIO2018-03-23
10694644300687RDSAMERICAN BIO MEDICA CORPORATIONDIO2018-02-13
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.DIO2017-11-15
10694644200468RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDIO2017-10-18
10694644200451RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDIO2017-10-12
10694644200444RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDIO2017-06-29
10694644300663RDSAMERICAN BIO MEDICA CORPORATIONDIO2017-06-08
10694644300670RDSAMERICAN BIO MEDICA CORPORATIONDIO2017-06-08
10694644100423Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2017-06-08
10694644300649RDSAMERICAN BIO MEDICA CORPORATIONDIO2017-04-06