Alere iScreen Dx IS12-DX

GUDID 00817405020171

Urine Drug Screen Card for detection of 12 drugs, Amphetamine, Barbiturate, Benzodiazepine, Cocaine, Ecstasy, Marijuana, Methadone, Methamphetamine, Morphine, Oxycodone, Phencyclidine and Tricyclic Antidepressants, CLIA Waived

Instant Technologies, Inc.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical

• Primary Device ID: 00817405020171
• NIH Device Record Key: aa0bda0b-ea87-49c7-b86a-69f22682da18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alere iScreen Dx
• Version Model Number: IS12-DX
• Catalog Number: IS12-DX
• Company DUNS: 019410187
• Company Name: Instant Technologies, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-340-4029
• Email: xxx@xx.xx
• Phone: 1-800-340-4029
• Email: xxx@xx.xx
• Phone: 1-800-340-4029
• Email: xxx@xx.xx
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817405020171 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022355

FDA Product Code

• LFH: U.V. Spectrometry, Tricyclic Antidepressant Drugs

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-19

On-Brand Devices [Alere iScreen Dx]

• 00817405020218: Urine Drug Screen Card for detection of Oxycodone (OXY) single drug, CLIA Waived
• 00817405020195: Urine Drug Screen Card for detection of 10 drugs, Amphetamine, Barbiturate, Benzodiazepine, Bupr
• 00817405020188: Urine Drug Screen Card for detection of 5 drugs, Amphetamine, Cocaine, Marijuana, Methamphetamin
• 00817405020171: Urine Drug Screen Card for detection of 12 drugs, Amphetamine, Barbiturate, Benzodiazepine, Coca
• 00817405020164: Urine Drug Screen Card for detection of 10 drugs, Amphetamine, Barbiturate, Benzodiazepine, Coca
• 00817405020157: Urine Drug Screen Card for detection of 10 drugs, Amphetamine, Barbiturate, Benzodiazepine, Coca
• 00817405020140: Urine Drug Screen Card for detection of Buprenorphine (BUP) single drug, CLIA Waived
• 00817405020133: Urine Drug Screen Card for detection of Marijuana (THC) single drug, CLIA Waived
• 00817405020126: Urine Drug Screen Card for detection of Tricyclic Antidepressants (TCA) single drug, CLIA Waived
• 00817405020119: Urine Drug Screen Card for detection of Methadone (MTD) single drug, CLIA Waived
• 00817405020102: Urine Drug Screen Card for detection of Methamphetamine (MET) single drug, CLIA Waived
• 00817405020096: Urine Drug Screen Card for detection of Ecstasy (MDMA) single drug, CLIA Waived
• 00817405020089: Urine Drug Screen Card for detection of Morphine (MOP) single drug, CLIA Waived
• 00817405020072: Urine Drug Screen Card for detection of Cocaine (COC) single drug, CLIA Waived
• 00817405020065: Urine Drug Screen Card for detection of Benzodiazepine (BZO) single drug, CLIA Waived
• 00817405020058: Urine Drug Screen Card for detection of Barbiturate (BAR) single drug, CLIA Waived
• 00817405020041: Urine Drug Screen Card for detection of Amphetamine (AMP) single drug, CLIA Waived
• 00817405020034: Urine Drug Screen Card for detection of Phencyclidine (PCP) single drug, CLIA Waived