FDA.reportPublic FDA data

AlereTM iScreen®

Primary DI
10858945006581
Brand
AlereTM iScreen®
Company
Instant Technologies, Inc.
Model
IS1MET
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
LAFGas Chromatography, Methamphetamine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LAFGas Chromatography, MethamphetamineClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858945006581PrimaryGS10
00858945006584Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085894500658110858945006581
00858945006584008589450065848589450065840858945006584

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
B298307220DrugCheck Express Diagnostic Int'l, Inc.LAF2026-02-19
10841824104737EZ CLICKW.H.P.M. INC.LAF2024-07-25
16936983149751Discover milti-drug12 drugs rapid test cupHangzhou AllTest Biotech Co., Ltd.LAF2024-02-09
16936983144664DiscoverHangzhou AllTest Biotech Co., Ltd.LAF2023-11-30
16936983144671DiscoverHangzhou AllTest Biotech Co., Ltd.LAF2023-11-30
B298305250DrugCheck Express Diagnostic Int'l, Inc.LAF2023-11-30
10833143000067iCup™Instant Technologies, Inc.LAF2023-09-12
10817763022609First SignW.H.P.M. INC.LAF2022-11-17
20869419000209Express ResultsTM Quest DiagnosticsLAF2022-03-28
10841824104843NAW.H.P.M. INC.LAF2021-10-12
10841824104812ECO II Cup ®W.H.P.M. INC.LAF2021-09-10
10817815020683CRL Stat Dip CardW.H.P.M. INC.LAF2021-08-25
10841824104805NAW.H.P.M. INC.LAF2021-08-25
10841824104782ECO II Cup ®W.H.P.M. INC.LAF2021-07-08
B2983057210DrugCheckExpress Diagnostic Int'l, Inc.LAF2021-06-18
10817405021304iScreen™Instant Technologies, Inc.LAF2020-08-21
10817405021311iScreen™Instant Technologies, Inc.LAF2020-08-21
10817405021328iScreen™Instant Technologies, Inc.LAF2020-08-21
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LAF2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LAF2020-06-18
10858886006480NOBLE NOBLE MEDICAL INCLAF2020-04-21
B2983044510DrugCheckExpress Diagnostic Int'l, Inc.LAF2019-04-23
B2983050110DrugCheckExpress Diagnostic Int'l, Inc.LAF2019-04-23
B2983050410DrugCheckExpress Diagnostic Int'l, Inc.LAF2019-04-23
B2983050810DrugCheckExpress Diagnostic Int'l, Inc.LAF2019-04-23
B2983055410DrugCheckExpress Diagnostic Int'l, Inc.LAF2019-04-23
B2983056010DrugCheckExpress Diagnostic Int'l, Inc.LAF2019-04-23
B2983058010DrugCheckExpress Diagnostic Int'l, Inc.LAF2019-04-23
B2983060010DrugCheckExpress Diagnostic Int'l, Inc.LAF2019-04-23
B2983069510DrugCheckExpress Diagnostic Int'l, Inc.LAF2019-04-23