Alere iCup Dx Pro I-DXP-1117-01

GUDID 00817405020300

Urine Drug Screening Device for detection of Amphetamine, Barbiturate, Benzodiazepine, Cocaine, Ecstasy, Marijuana, Methamphetamine, Methadone, Opiate (300), Oxycodone and Tricyclic Antidepressants with adulteration tests for Oxidant, pH and Specific Gravity. CLIA Waived Test Cup

Instant Technologies, Inc.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00817405020300
NIH Device Record Keyff745b4e-913e-475d-970e-332d7c8c214f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlere iCup Dx Pro
Version Model NumberI-DXP-1117-01
Catalog NumberI-DXP-1117-01
Company DUNS019410187
Company NameInstant Technologies, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-340-4029
Emailxxx@xx.xx
Phone1-800-340-4029
Emailxxx@xx.xx
Phone1-800-340-4029
Emailxxx@xx.xx
Phone1-800-340-4029
Emailxxx@xx.xx
Phone1-800-340-4029
Emailxxx@xx.xx
Phone1-800-340-4029
Emailxxx@xx.xx
Phone1-800-340-4029
Emailxxx@xx.xx
Phone1-800-340-4029
Emailxxx@xx.xx
Phone1-800-340-4029
Emailxxx@xx.xx
Phone1-800-340-4029
Emailxxx@xx.xx
Phone1-800-340-4029
Emailxxx@xx.xx
Phone1-800-340-4029
Emailxxx@xx.xx
Phone1-800-340-4029
Emailxxx@xx.xx
Phone1-800-340-4029
Emailxxx@xx.xx
Phone1-800-340-4029
Emailxxx@xx.xx
Phone1-800-340-4029
Emailxxx@xx.xx
Phone1-800-340-4029
Emailxxx@xx.xx
Phone1-800-340-4029
Emailxxx@xx.xx
Phone1-800-340-4029
Emailxxx@xx.xx
Phone1-800-340-4029
Emailxxx@xx.xx
Phone1-800-340-4029
Emailxxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100817405020300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NFWTest, Cannabinoid, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-14

On-Brand Devices [Alere iCup Dx Pro]

00817405020317Urine Drug Screening Device for detection of Amphetamine, Barbiturate, Benzodiazepine, Cocaine,
00817405020300Urine Drug Screening Device for detection of Amphetamine, Barbiturate, Benzodiazepine, Cocaine,
00817405020294Alere iCup DX Pro Integrated CLIA Waived Urine Drug Screening Device THC50, COC300, OPI300, AMP1

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