ETHANOL 76 MG/DL ETH 76 WB F OSBI

GUDID B800ETH76WBFOSBI5

ETHANOL 76 MG/DL

UTAK LABORATORIES, INC.

Multiple-type clinical chemistry analyte profile IVD, control
Primary Device IDB800ETH76WBFOSBI5
NIH Device Record Keyea712179-3aab-4373-9cb2-dcaf18bdd43d
Commercial Distribution StatusIn Commercial Distribution
Brand NameETHANOL 76 MG/DL
Version Model NumberETH 76 WB F OSBI
Catalog NumberETH 76 WB F OSBI
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

Device Dimensions

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB800ETH76WBFOSBI0 [Primary]
HIBCCB800ETH76WBFOSBI5 [Package]
Contains: B800ETH76WBFOSBI0
Package: BOX [10 Units]
Discontinued: 2026-02-23
Not 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 Date2026-03-03
Device Publish Date2026-02-23

On-Brand Devices [ETHANOL 76 MG/DL]

B800ETH76WBFOSBI5ETHANOL 76 MG/DL
B800ETH177WBFOSBI5ETHANOL 76 MG/DL

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