ANTI5V2SFUNC ANTI 5 V2 S F UNC

GUDID B800ANTI5V2SFUNC5

ANTI5V2SFUNC

UTAK LABORATORIES, INC.

Multiple-type clinical chemistry analyte profile IVD, control
Primary Device IDB800ANTI5V2SFUNC5
NIH Device Record Key2d86d288-0c78-4205-b285-ba062d4003ed
Commercial Distribution StatusIn Commercial Distribution
Brand NameANTI5V2SFUNC
Version Model NumberANTI 5 V2 S F UNC
Catalog NumberANTI 5 V2 S F UNC
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

Phone888-882-5522
Emailwelovecontrol@UTAK.COM
Phone888-882-5522
Emailwelovecontrol@UTAK.COM
Phone888-882-5522
Emailwelovecontrol@UTAK.COM
Phone888-882-5522
Emailwelovecontrol@UTAK.COM
Phone888-882-5522
Emailwelovecontrol@UTAK.COM
Phone888-882-5522
Emailwelovecontrol@UTAK.COM
Phone888-882-5522
Emailwelovecontrol@UTAK.COM
Phone888-882-5522
Emailwelovecontrol@UTAK.COM
Phone888-882-5522
Emailwelovecontrol@UTAK.COM
Phone888-882-5522
Emailwelovecontrol@UTAK.COM
Phone888-882-5522
Emailwelovecontrol@UTAK.COM
Phone888-882-5522
Emailwelovecontrol@UTAK.COM
Phone888-882-5522
Emailwelovecontrol@UTAK.COM
Phone888-882-5522
Emailwelovecontrol@UTAK.COM
Phone888-882-5522
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
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB800ANTI5V2SFUNC0 [Primary]
HIBCCB800ANTI5V2SFUNC5 [Package]
Contains: B800ANTI5V2SFUNC0
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 Date2024-08-14
Device Publish Date2024-08-06

Devices Manufactured by UTAK LABORATORIES, INC.

B80088121CDFF10NJSP5 - CERTIFIED DRUG FREE URINE2024-09-26 CERTIFIED DRUG FREE URINE
B800DAU1V2NJSP5 - DRUGS OF ABUSE LEVEL 12024-09-26 DRUGS OF ABUSE LEVEL 1
B800DAU2V2NJSP5 - DRUGS OF ABUSE LEVEL 22024-09-26 DRUGS OF ABUSE LEVEL 2
B800DAU3NJSP5 - DRUGS OF ABUSE LEVEL 32024-09-26 DRUGS OF ABUSE LEVEL 3
B800DAU4NJSP5 - DRUGS OF ABUSE LEVEL 4 2024-09-26 DRUGS OF ABUSE LEVEL 4
B800FENT1V2UNJSP5 - FENTANYL PLUS LEVEL 1 2024-09-26 FENTANYL PLUS LEVEL 1
B800FENT1WBNJSP5 - FENTANYL PLUS LEVEL 1 2024-09-26 FENTANYL PLUS LEVEL 1
B800FENT2V2UNJSP5 - FENTANYL PLUS LEVEL 22024-09-26 FENTANYL PLUS LEVEL 2

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