Mission Saliva Test Strips

GUDID 20682607200058

Mission Saliva Alcohol Test Strips

ACON LABORATORIES, INC.

Ethanol (ETOH) IVD, kit, colorimetric, rapid
Primary Device ID20682607200058
NIH Device Record Key96e37f4c-a20f-4aa8-8822-24304df923e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameMission Saliva Test Strips
Version Model NumberC031-021
Company DUNS781100966
Company NameACON LABORATORIES, INC.
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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-Countertrue

Customer Support Contacts

Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100682607000272 [Unit of Use]
GS100682607200054 [Primary]
GS120682607200058 [Package]
Contains: 00682607200054
Package: Carton [80 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DICALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-26

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