EIA C1 V3 EIA C1 V3 WB DOJ

GUDID B800EIAC1V3WBDOJ5

EIA C1 V3

UTAK LABORATORIES, INC.

Multiple-type clinical chemistry analyte profile IVD, control
Primary Device IDB800EIAC1V3WBDOJ5
NIH Device Record Keyfc063669-d4de-4698-bcfa-0ce864ea65a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameEIA C1 V3
Version Model NumberEIA C1 V3 WB DOJ
Catalog NumberEIA C1 V3 WB DOJ
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

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

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB800EIAC1V3WBDOJ0 [Primary]
HIBCCB800EIAC1V3WBDOJ5 [Package]
Contains: B800EIAC1V3WBDOJ0
Package: BOX [20 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 Date2024-04-01
Device Publish Date2024-03-22

Devices Manufactured by UTAK LABORATORIES, INC.

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B800THCV2SWSLH5 - THC PLUS2024-07-11 THC PLUS
B800DA1WBIMMUN5 - DRUGS OF ABUSE PLUS LEVEL 12024-07-09 DRUGS OF ABUSE PLUS LEVEL 1
B800DA2WBIMMUN0 - DRUGS OF ABUSE PLUS LEVEL 22024-07-09 DRUGS OF ABUSE PLUS LEVEL 2
B800DA3WBIMMUN0 - DRUGS OF ABUSE PLUS LEVEL 32024-07-09 DRUGS OF ABUSE PLUS LEVEL 3
B800DA4WBIMMUN5 - DRUGS OF ABUSE PLUS LEVEL 42024-07-09 DRUGS OF ABUSE PLUS LEVEL 4
B800BENZOYL1FAPTC5 - BENZOYLECGONINE LEVEL 1 2024-07-08 BENZOYLECGONINE LEVEL 1

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