LEAD LEVEL 2 LEAD 2 WB F BCH

GUDID B800LEAD2WBFBCH5

LEAD LEVEL 2

UTAK LABORATORIES, INC.

Multiple-type clinical chemistry analyte profile IVD, control
Primary Device IDB800LEAD2WBFBCH5
NIH Device Record Key177c5719-a6ac-4ba6-9cae-9be83b3c9f93
Commercial Distribution StatusIn Commercial Distribution
Brand NameLEAD LEVEL 2
Version Model NumberLEAD 2 WB F BCH
Catalog NumberLEAD 2 WB F BCH
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
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
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
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
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
Total Volume5 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
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
HIBCCB800LEAD2WBFBCH0 [Primary]
HIBCCB800LEAD2WBFBCH5 [Package]
Contains: B800LEAD2WBFBCH0
Package: BOX [5 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 Date2024-04-02
Device Publish Date2024-03-25

On-Brand Devices [LEAD LEVEL 2]

B800933125Lead Level 2
B800LEAD2WBFUMMC5LEAD LEVEL 2
B800LEAD2WBVWDL5LEAD LEVEL 2
B800LEAD2WBFUCI5LEAD LEVEL 2
B800LEAD2WBFLGC5LEAD LEVEL 2
B800LEAD2WBFBCH5LEAD LEVEL 2

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