FDA.reportPublic FDA data

AlereTM iScreen®

Primary DI
10858945006574
Brand
AlereTM iScreen®
Company
Instant Technologies, Inc.
Model
IS1MOP
Published
2016-09-24
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DJGEnzyme Immunoassay, Opiates

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858945006574PrimaryGS10
00858945006577Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085894500657410858945006574
00858945006577008589450065778589450065770858945006577

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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30817405024118iScreen™ ABTDOAW110701AABTDOAW110701A2024-08-06
10817405024077iScreen™ Urine Test E-Z Split Key™ Drug Screen CupDUE-197-341DUE-197-3412024-07-16
10817405024084iScreen™ Urine Test E-Z Split Key™ Drug Screen CupDUE-1107-541DUE-1107-5412024-07-16
10817405024107iScreen™ Urine Test E-Z Split Key™ Drug Screen CupDUE-187-311DUE-187-3112024-07-16
30817405024033iScreen™ABTOFCUBE0903CABTOFCUBE0903C2023-12-28
30817405024040iScreen™ABTOFCUBE1102BABTOFCUBE1102B2023-12-28
30817405024057iScreen™ABTOFCUBE0502BABTOFCUBE0502B2023-12-07
30817405024064iScreen™ABTOFCUBE0605EABTOFCUBE0605E2023-12-07
30817405024026iCassetteABTDFYW11201AABTDFYW11201A2023-11-30
30817405024002iScreen™ABTDOAW105401AABTDOAW105401A2023-05-25
30817405024019iScreen™ABTDOAW105402BABTDOAW105402B2023-05-25
30817405023814iScreen™ABTDUAW112705EABTDUAW112705E2023-05-01
30817405023821iScreen™ABTDOAW111701AABTDOAW111701A2023-05-01
30817405023838iScreen™ABTDUAW112706FABTDUAW112706F2023-05-01
30817405023845iScreen™ABTDUAW114703CABTDUAW114703C2023-05-01
30817405023852iScreen™ABTDOAW15701AABTDOAW15701A2023-05-01
30817405023869iScreen™ABTDOAW15702BABTDOAW15702B2023-05-01
30817405023876iScreen™ABTDOAW114701AABTDOAW114701A2023-05-01
30817405023883iScreen™ABTDUAW114704DABTDUAW114704D2023-05-01
30817405023890iScreen™ABTOFCUBE1101AABTOFCUBE1101A2023-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
80810164510071Atida Fentanyl Drug of Abuse Test RxACESO LABORATORIES INC.DJG2026-03-23
10810173655979HealgenHealgen Scientific Limited Liability CompanyDJG2026-03-11
10810173655986HealgenHealgen Scientific Limited Liability CompanyDJG2026-03-11
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
10815845024237SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.DJG2024-12-17
10815845024268SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.DJG2024-12-17
10815845024398SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.DJG2024-12-17
00812101031001DRI Tramadol Assay - 500 mLARK DIAGNOSTICS INCDJG2024-11-14
00812101031018DRI Tramadol Assay - 115mLARK DIAGNOSTICS INCDJG2024-11-14
00812101031025DRI Tramadol Negative Calibrator KitARK DIAGNOSTICS INCDJG2024-11-14
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
10810124273153SureStep™ Urine Test E-Z Split Key™ Drug Screen CupALERE SAN DIEGO, INC.DJG2024-09-17