DRUGS OF ABUSE LEVEL 3 DAU 3 NJSP

GUDID B800DAU3NJSP5

DRUGS OF ABUSE LEVEL 3

UTAK LABORATORIES, INC.

Multiple-type clinical chemistry analyte profile IVD, control
Primary Device IDB800DAU3NJSP5
NIH Device Record Keye40a26d7-f26c-4c2b-bb6b-c60c593770d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRUGS OF ABUSE LEVEL 3
Version Model NumberDAU 3 NJSP
Catalog NumberDAU 3 NJSP
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

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

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB800DAU3NJSP0 [Primary]
HIBCCB800DAU3NJSP5 [Package]
Contains: B800DAU3NJSP0
Package: BOX [25 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 Date2024-09-26
Device Publish Date2024-09-18

On-Brand Devices [DRUGS OF ABUSE LEVEL 3]

B80002041000031DRUGS OF ABUSE LEVEL 3
B800DA3WBFRIDH5DRUGS OF ABUSE LEVEL 3
B800DAUCAL3V3FNHI5DRUGS OF ABUSE LEVEL 3
B800DAU3V2FUVMG0DRUGS OF ABUSE LEVEL 3
B800DAU3FLE5DRUGS OF ABUSE LEVEL 3
B800DOA3SMXOFMMC5DRUGS OF ABUSE LEVEL 3
B800SMXDAU3FPG5DRUGS OF ABUSE LEVEL 3
B800SMXDAU3V2FPG5DRUGS OF ABUSE LEVEL 3
B800DAU3FOSUMC5DRUGS OF ABUSE LEVEL 3
B800DAU3NJSP5DRUGS OF ABUSE LEVEL 3

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