DRUGS OF ABUSE LEVEL 1 V3 DA 1 V3 WB LASD

GUDID B800DA1V3WBLASD5

DRUGS OF ABUSE LEVEL 1 V3

UTAK LABORATORIES, INC.

Multiple drugs of abuse IVD, control
Primary Device IDB800DA1V3WBLASD5
NIH Device Record Key6f95bfde-18cc-463c-9ff3-3165ce134e53
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRUGS OF ABUSE LEVEL 1 V3
Version Model NumberDA 1 V3 WB LASD
Catalog NumberDA 1 V3 WB LASD
Company DUNS092519016
Company NameUTAK LABORATORIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Phone1-888-882-5522
Emailwelovecontrol@utak.com
Phone1-888-882-5522
Emailwelovecontrol@utak.com
Phone1-888-882-5522
Emailwelovecontrol@utak.com
Phone1-888-882-5522
Emailwelovecontrol@utak.com
Phone1-888-882-5522
Emailwelovecontrol@utak.com
Phone1-888-882-5522
Emailwelovecontrol@utak.com
Phone1-888-882-5522
Emailwelovecontrol@utak.com
Phone1-888-882-5522
Emailwelovecontrol@utak.com
Phone1-888-882-5522
Emailwelovecontrol@utak.com
Phone1-888-882-5522
Emailwelovecontrol@utak.com
Phone1-888-882-5522
Emailwelovecontrol@utak.com
Phone1-888-882-5522
Emailwelovecontrol@utak.com
Phone1-888-882-5522
Emailwelovecontrol@utak.com
Phone1-888-882-5522
Emailwelovecontrol@utak.com
Phone1-888-882-5522
Emailwelovecontrol@utak.com
Phone1-888-882-5522
Emailwelovecontrol@utak.com
Phone1-888-882-5522
Emailwelovecontrol@utak.com
Phone1-888-882-5522
Emailwelovecontrol@utak.com

Device Dimensions

Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB800DA1V3WBLASD0 [Primary]
HIBCCB800DA1V3WBLASD5 [Package]
Contains: B800DA1V3WBLASD0
Package: Box [20 Units]
In Commercial Distribution

FDA Product Code

LASDrug Specific Control Materials

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-08
Device Publish Date2023-02-28

On-Brand Devices [DRUGS OF ABUSE LEVEL 1 V3]

B800DA1V3WBLASD5DRUGS OF ABUSE LEVEL 1 V3
B800DAU1V3UFTFOC5DRUGS OF ABUSE LEVEL 1 V3
B800DAU1V3FVMG5DRUGS OF ABUSE LEVEL 1 V3

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