DAU LEVEL 1 DAU 1 F V2 UTMB

GUDID B800DAU1FV2UTMB5

DAU LEVEL 1

UTAK LABORATORIES, INC.

Multiple drugs of abuse IVD, control
Primary Device IDB800DAU1FV2UTMB5
NIH Device Record Key42568dc8-302a-4666-96a2-52f10719a4c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameDAU LEVEL 1
Version Model NumberDAU 1 F V2 UTMB
Catalog NumberDAU 1 F V2 UTMB
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

Phone8888825522
Emailwelovecontrol@utak.com
Phone8888825522
Emailwelovecontrol@utak.com
Phone8888825522
Emailwelovecontrol@utak.com
Phone8888825522
Emailwelovecontrol@utak.com
Phone8888825522
Emailwelovecontrol@utak.com
Phone8888825522
Emailwelovecontrol@utak.com
Phone8888825522
Emailwelovecontrol@utak.com
Phone8888825522
Emailwelovecontrol@utak.com
Phone8888825522
Emailwelovecontrol@utak.com
Phone8888825522
Emailwelovecontrol@utak.com
Phone8888825522
Emailwelovecontrol@utak.com
Phone8888825522
Emailwelovecontrol@utak.com
Phone8888825522
Emailwelovecontrol@utak.com
Phone8888825522
Emailwelovecontrol@utak.com
Phone8888825522
Emailwelovecontrol@utak.com
Phone8888825522
Emailwelovecontrol@utak.com
Phone8888825522
Emailwelovecontrol@utak.com

Device Dimensions

Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 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
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
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
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
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
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
HIBCCB800DAU1FV2UTMB0 [Primary]
HIBCCB800DAU1FV2UTMB5 [Package]
Contains: B800DAU1FV2UTMB0
Package: BOX [50 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 Date2024-05-23
Device Publish Date2024-05-15

On-Brand Devices [DAU LEVEL 1]

B800DAU1DTPM0DAU LEVEL 1
B800DAU1V2FSMA5DAU LEVEL 1
B800DAU1V8FUVHS5DAU LEVEL 1
B800DAU1ABS0DAU LEVEL 1
B800DAU1FV2UTMB5DAU LEVEL 1
B800DAU1V9FUVHS5DAU LEVEL 1

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