SELENIUM 100 UG/L SELEN 100 S BP

GUDID B800SELEN100SBP0

SELENIUM 100 UG/L

UTAK LABORATORIES, INC.

Multiple drugs of abuse IVD, control
Primary Device IDB800SELEN100SBP0
NIH Device Record Keyc60ad3c9-07ea-49a2-ab5e-f90b6d380e11
Commercial Distribution StatusIn Commercial Distribution
Brand NameSELENIUM 100 UG/L
Version Model NumberSELEN 100 S BP
Catalog NumberSELEN 100 S BP
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 Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB800SELEN100SBP0 [Primary]

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 Date2024-05-15
Device Publish Date2024-05-07

Devices Manufactured by UTAK LABORATORIES, INC.

B800DAUNEGFV3UVHS5 - DAU NEGATIVE V32024-10-17 DAU NEGATIVE V3
B800DAUPOSFV3UVHS5 - DAU POSITIVE V32024-10-17 DAU POSITIVE V3
B800CDFUL12GALJNC5 - CERTIFIED DRUG FREE URINE2024-10-11 CERTIFIED DRUG FREE URINE
B800VOLHIGHSULH5 - VOLATILES HIGH2024-10-10 VOLATILES HIGH
B800QCA1OFFWHPM5 - DRUGS OF ABUSE QC A LEVEL 1 2024-10-09 DRUGS OF ABUSE QC A LEVEL 1
B800QCA2OFFWHPM5 - DRUGS OF ABUSE QC A LEVEL 22024-10-09 DRUGS OF ABUSE QC A LEVEL 2
B800QCA3OFFWHPM5 - DRUGS OF ABUSE QC A LEVEL 32024-10-09 DRUGS OF ABUSE QC A LEVEL 3
B80090000UFLTI5 - NICOTINE PLUS LEVEL 12024-10-08 NICOTINE PLUS LEVEL 1

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.