Urine Dip Card ATS-TRAM

GUDID 00858945006935

Single Drug Urine Test Panel, Opiates, Employment and Insurance Testing, Exempt: TRA.

Instant Technologies, Inc.

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Primary Device ID00858945006935
NIH Device Record Key3492712c-8832-44c8-b5b5-816ae067d980
Commercial Distribution StatusIn Commercial Distribution
Brand NameUrine Dip Card
Version Model NumberATS-TRAM
Catalog NumberATS-TRAM
Company DUNS019410187
Company NameInstant Technologies, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-340-4029
Emaillisa.bates@alere.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

Device Identifiers

Device Issuing AgencyDevice ID
GS100858945006935 [Primary]

FDA Product Code

PVHTest, Opiates, Employment And Insurance Testing, Exempt

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2018-02-09

On-Brand Devices [Urine Dip Card]

00858945006959Single Drug Urine Test Panel, Fentanly, Employment And Insurance Testing, Exempt: FTY.
00858945006942Single Drug Urine Test Panel, Synthetic Cannabinoids, Employment And Insurance Testing, Exempt:
00858945006935Single Drug Urine Test Panel, Opiates, Employment and Insurance Testing, Exempt: TRA.

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