Alere iCup Dx I-DXA-187-016

GUDID 00817405020256

Drugs of Abuse Test Cup for detection of (MET1000/OPI2000)+AMP+BZO+COC+MTD+OXY+THC with adulteration tests Cr, Ni,pH, Bl, S.G., CLIA Waived

Instant Technologies, Inc.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00817405020256
NIH Device Record Key189adce0-5cc4-43f3-a08e-1adac82e2e78
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlere iCup Dx
Version Model NumberI-DXA-187-016
Catalog NumberI-DXA-187-016
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-Counterfalse

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
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com
Phone1-800-340-4029
EmailQa.Portsmouth@abbott.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100817405020256 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DJREnzyme Immunoassay, Methadone

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 Date2016-09-19

On-Brand Devices [Alere iCup Dx]

00817405020386Alere iCUP DX (THC50/COC150)+(MOP300/MET500)+(AMP500/BZO300)+(BAR300/MTD300)+(MDMA500/OXY100) Wi
00817405020379Alere iCUP DX (THC50/COC150)+(MOP300/MET500)+(AMP500/BZO300)+(BAR300/MTD300)+(MDMA500/OXY100) +(
00817405020348Drugs of Abuse Test Cup for detection of BZO+BAR+(MET/OPI)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)+COC wi
00817405020331Drugs of Abuse Test Cup for detection of BZO+BAR+(MET1000/OPI2000)+(OXY/MDMA)+AMP+COC+MTD+THC wi
00817405020324Drugs of Abuse Test Cup for detection of BZO+BAR+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA
00817405020263Drugs of Abuse Test Cup for detection of (BZO/BAR)+(MET/OPI)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)+COC
00817405020256Drugs of Abuse Test Cup for detection of (MET1000/OPI2000)+AMP+BZO+COC+MTD+OXY+THC with adultera
00817405020249Drugs of Abuse Test Cup for detection of (BZO/BAR)+(MET1000/OPI2000)+(OXY/MDMA)+AMP+COC+MTD+THC
00817405020232Drugs of Abuse Test Cup for detection of (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MD
00817405020225Drugs of Abuse Test Cup for detection of COC/THC/OPI/MET/BZO/OXY with adulteration tests Cr, Ni,
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