FDA.reportPublic FDA data

Alere iCup Dx Pro

Primary DI
00817405020317
Brand
Alere iCup Dx Pro
Company
Instant Technologies, Inc.
Model
I-DXP-1127-02
Catalog number
I-DXP-1127-02
Device description
Urine Drug Screening Device for detection of Amphetamine, Barbiturate, Benzodiazepine, Cocaine, Ecstasy, Marijuana, Methamphetamine, Methadone, Opiate (300), Oxycodone, Phencyclidine and Tricyclic Antidepressants. CLIA Waived Test Cup
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DISEnzyme Immunoassay, Barbiturate
DJREnzyme Immunoassay, Methadone
LCMEnzyme Immunoassay, Phencyclidine
LFGRadioimmunoassay, Tricyclic Antidepressant Drugs
NFTTest, Amphetamine, Over The Counter
NFVTest, Benzodiazepine, Over The Counter
NFWTest, Cannabinoid, Over The Counter
NFYTest, Cocaine And Cocaine Metabolites, Over The Counter
NGGTest, Methamphetamine, Over The Counter
NGLTest, Opiates, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DISEnzyme Immunoassay, BarbiturateClinical Toxicology2
DJREnzyme Immunoassay, MethadoneClinical Toxicology2
LCMEnzyme Immunoassay, PhencyclidineUnknownU
LFGRadioimmunoassay, Tricyclic Antidepressant DrugsClinical Toxicology2
NFTTest, Amphetamine, Over The CounterClinical Toxicology2
NFVTest, Benzodiazepine, Over The CounterClinical Toxicology2
NFWTest, Cannabinoid, Over The CounterClinical Toxicology2
NFYTest, Cocaine And Cocaine Metabolites, Over The CounterClinical Toxicology2
NGGTest, Methamphetamine, Over The CounterClinical Toxicology2
NGLTest, Opiates, Over The CounterClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082898000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082898000AMEDICA DRUG SCREEN TEST CUPAmedica Biotech, Inc.2008-12-19NGL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817405020317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817405020317008174050203178174050203170817405020317

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-340-4029xxx@xx.xx

Regulatory Flags#

DUNS number
019410187
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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00817405021192UScreen®USSCupA-12CLIAUSSCUPA-12CLIA2021-01-13
00817405021222UScreen®USSCup-10MMO300USSCup-10MMO3002021-01-13
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10817405021311iScreen™IS12-DX2 IS12-DX2 2020-08-21
10817405021328iScreen™IS12BUP-DX2 IS12BUP-DX2 2020-08-21
10817405021373UScreen®USSCupA-11CLIALCUSSCupA-11CLIALC2021-05-25
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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

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