DRUGS OF ABUSE CAL

GUDID B80010029000030

UTAK LABORATORIES, INC.

Multiple therapeutic drugs/drugs of abuse IVD, control
Primary Device IDB80010029000030
NIH Device Record Key2429257c-b111-4d79-9b17-9944add04309
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRUGS OF ABUSE CAL
Version Model NumberDA CAL M LB
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB80010029000030 [Primary]
HIBCCB80010029000031 [Package]
Package: Box [4 Units]
In Commercial Distribution
HIBCCB80010029000032 [Package]
Package: Box [5 Units]
In Commercial Distribution
HIBCCB80010029000033 [Package]
Package: Box [10 Units]
In Commercial Distribution
HIBCCB80010029000036 [Package]
Package: Box [25 Units]
In Commercial Distribution
HIBCCB80010029000037 [Package]
Package: Box [50 Units]
In Commercial Distribution
HIBCCB80010029000038 [Package]
Package: Box [100 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 Date2022-05-12
Device Publish Date2022-05-04

On-Brand Devices [DRUGS OF ABUSE CAL]

B80010029000011DA+ CAL M LB
B80010029000030DA CAL M LB
B800DAMCALRDL5DRUGS OF ABUSE CAL

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