MPA LEVEL 3 MPA 3 S V POTM

GUDID B800MPA3SVPOTM5

MPA LEVEL 3

UTAK LABORATORIES, INC.

Multiple-type clinical chemistry analyte profile IVD, control
Primary Device IDB800MPA3SVPOTM5
NIH Device Record Keyd6e1cec0-cde0-4735-8acb-e68fcd308716
Commercial Distribution StatusIn Commercial Distribution
Brand NameMPA LEVEL 3
Version Model NumberMPA 3 S V POTM
Catalog NumberMPA 3 S V POTM
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

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

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB800MPA3SVPOTM0 [Primary]
HIBCCB800MPA3SVPOTM5 [Package]
Contains: B800MPA3SVPOTM0
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 Date2025-05-28
Device Publish Date2025-05-20

Devices Manufactured by UTAK LABORATORIES, INC.

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B800MPA3SVPOTM5 - MPA LEVEL 32025-05-28MPA LEVEL 3
B800MPA3SVPOTM5 - MPA LEVEL 32025-05-28 MPA LEVEL 3
B800AMPH2UV4FWBH5 - AMPHETAMINE PLUS LEVEL 2 V42025-05-21 AMPHETAMINE PLUS LEVEL 2 V4
B800COT25SWDL5 - COTININE PLUS 25 NG/ML2025-05-21 COTININE PLUS 25 NG/ML
B800COT5SWDL5 - COTININE PLUS 5 NG/ML2025-05-21 COTININE PLUS 5 NG/ML
B800CREAALDD5 - CREATININE PLUS2025-05-21 CREATININE PLUS
B800GABA1V3SMXUFPG5 - GABAPENTIN LEVEL 12025-05-16 GABAPENTIN LEVEL 1
B800GABA2V2SMXUFPG5 - GABAPENTIN LEVEL 22025-05-16 GABAPENTIN LEVEL 2

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