Single Drug Urine Test Panel AWDMD-114

GUDID 00817405021123

MDMA Single Drug Urine Test Panel

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, 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 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 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 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 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 ID00817405021123
NIH Device Record Key0859dc42-91df-4d6f-9e07-01b2c6d81e43
Commercial Distribution StatusIn Commercial Distribution
Brand NameSingle Drug Urine Test Panel
Version Model NumberAWDMD-114
Catalog NumberAWDMD-114
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
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
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 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100817405021123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LAFGas Chromatography, Methamphetamine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-18
Device Publish Date2020-03-10

On-Brand Devices [Single Drug Urine Test Panel]

00817405021123MDMA Single Drug Urine Test Panel
00817405021093Morphine (MOP) Single Drug Urine Test Panel

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