DRUGS OF ABUSE QC DAU QC F NSPCL

GUDID B800DAUQCFNSPCL5

DRUGS OF ABUSE QC

UTAK LABORATORIES, INC.

Multiple-type clinical chemistry analyte profile IVD, control
Primary Device IDB800DAUQCFNSPCL5
NIH Device Record Key2912ab6a-8033-448f-9eaa-242bfa6ea184
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRUGS OF ABUSE QC
Version Model NumberDAU QC F NSPCL
Catalog NumberDAU QC F NSPCL
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

Device Dimensions

Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB800DAUQCFNSPCL0 [Primary]
HIBCCB800DAUQCFNSPCL5 [Package]
Contains: B800DAUQCFNSPCL0
Package: BOX [17 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 Date2025-09-01
Device Publish Date2025-08-22

On-Brand Devices [DRUGS OF ABUSE QC]

B80010029000020DA+ QC M LB
B800DAUQCFNSPCL5DRUGS OF ABUSE QC

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