FDA.reportPublic FDA data

AlereTM iScreen®

Primary DI
10858945006536
Brand
AlereTM iScreen®
Company
Instant Technologies, Inc.
Model
IS1AMP
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
LAFGas Chromatography, Methamphetamine

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858945006536PrimaryGS10
00858945006539Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085894500653610858945006536
00858945006539008589450065398589450065390858945006539

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
10810173655948HealgenHealgen Scientific Limited Liability CompanyLAF2026-03-11
10810173654804HealgenHealgen Scientific Limited Liability CompanyLAF2026-01-08
10810173654552HealgenHealgen Scientific Limited Liability CompanyLAF2025-12-19
00812203030810DrugSmartCHEMTRON BIOTECH INCLAF2025-09-26
00841824105645N/AW.H.P.M. INC.LAF2025-06-13
00812203030858GenericCHEMTRON BIOTECH INCLAF2025-02-24
00812203030797GenericCHEMTRON BIOTECH INCLAF2024-07-29
00812203030766Premier BiotechCHEMTRON BIOTECH INCLAF2024-05-28
00812203030728GenericCHEMTRON BIOTECH INCLAF2024-04-09
00812203030735Premier BiotechCHEMTRON BIOTECH INCLAF2024-04-08
00812203030674GenericCHEMTRON BIOTECH INCLAF2024-02-05
00812203030667GenericCHEMTRON BIOTECH INCLAF2024-02-01
10810124273047SureStepTM Urine Test Drug Screen Strip, Methamphetamine (MET 500)ALERE SAN DIEGO, INC.LAF2023-12-15
10810124273054SureStepTM Urine Test Drug Screen Strip, Methylenedioxymethamphetamine (MDMA 500ALERE SAN DIEGO, INC.LAF2023-12-15
10810124273214SureStepTM Urine Test Drug Screen Strip, Methamphetamine (MET 1000)ALERE SAN DIEGO, INC.LAF2023-12-15
10810124273313SureStepTM Urine Drug Test CassetteALERE SAN DIEGO, INC.LAF2023-12-15
30817405021483iScreen™Instant Technologies, Inc.LAF2023-02-07
30817405021506iScreen™Instant Technologies, Inc.LAF2023-02-07
30817405021520iScreen™Instant Technologies, Inc.LAF2023-02-07
30817405021537iScreen™Instant Technologies, Inc.LAF2023-02-07
30817405021605iScreen™Instant Technologies, Inc.LAF2023-02-07
30817405021612iScreen™Instant Technologies, Inc.LAF2023-02-07
30817405021674iScreen™Instant Technologies, Inc.LAF2023-02-07
30817405021728iScreen™Instant Technologies, Inc.LAF2023-02-07
30817405021735iScreen™Instant Technologies, Inc.LAF2023-02-07
30817405021902iScreen™Instant Technologies, Inc.LAF2023-02-07
30817405021926iScreen™Instant Technologies, Inc.LAF2023-02-07
30817405021933iScreen™Instant Technologies, Inc.LAF2023-02-07
30817405021940iScreen™Instant Technologies, Inc.LAF2023-02-07
30817405021957iScreen™Instant Technologies, Inc.LAF2023-02-07