FDA.report

AlereTM iCassette®

Primary DI
10858945006642
Brand
AlereTM iCassette®
Company
Instant Technologies, Inc.
Model
I-DAM-102
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
LAFGas Chromatography, Methamphetamine

Product Code Classifications

CodeDeviceSpecialtyClass
LAFGas Chromatography, MethamphetamineClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10858945006642PrimaryGS10
00858945006645Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1085894500664210858945006642
00858945006645008589450066458589450066450858945006645

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

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10817405024084iScreen™ Urine Test E-Z Split Key™ Drug Screen CupDUE-1107-541DUE-1107-5412024-07-16
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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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00812203030735Premier BiotechCHEMTRON BIOTECH INCLAF2024-04-08
00812203030674GenericCHEMTRON BIOTECH INCLAF2024-02-05
00812203030667GenericCHEMTRON BIOTECH INCLAF2024-02-01
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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
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