FDA.report

AlereTM iScreen®

Primary DI
10858945006352
Brand
AlereTM iScreen®
Company
Instant Technologies, Inc.
Model
I-DOA-194-191
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

Related Records

Contact Domains

Product Codes

CodeName
LFGRadioimmunoassay, Tricyclic Antidepressant Drugs

Product Code Classifications

CodeDeviceSpecialtyClass
LFGRadioimmunoassay, Tricyclic Antidepressant DrugsClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10858945006352PrimaryGS10
00858945006355Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1085894500635210858945006352
00858945006355008589450063558589450063550858945006355

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

Contacts

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

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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

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10810173654521Healgen Healgen Scientific Limited Liability CompanyLFG2025-12-19
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10815845023797SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.LFG2024-12-17
10810124273085SureStepTM Urine Test Drug Screen Strip, Tricyclic Antidepressants (TCA 1000)ALERE SAN DIEGO, INC.LFG2023-12-15
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10816862021780PreviewWONDFO USA CO., LTD.LFG2019-12-22
20817038021631UCP Home Drug Screening Test CupsUCP BIOSCIENCES, INC.LFG2017-01-20
20817038021730UCP Compact Drug Test Cups UCP BIOSCIENCES, INC.LFG2017-01-20
20817038021778UCP Drug Test Mini Cups UCP BIOSCIENCES, INC.LFG2017-01-20
20817038021815u-Cup Drug Test Screen UCP BIOSCIENCES, INC.LFG2017-01-20
20817038021860u-Cup Drug Test ScreenUCP BIOSCIENCES, INC.LFG2017-01-20
20817038021891UCP Compact Drug Test Cups UCP BIOSCIENCES, INC.LFG2017-01-20
00895330002790Healgen (Private Label) - 3124CONFIRM BIOSCIENCES, INC.LFG2016-11-15
20817038021136u-Cup Drug Test Screen UCP BIOSCIENCES, INC.LFG2016-10-24