Mission Urinary Tract Infection (UTI) Test strips

GUDID 20682607610031

ACON LABORATORIES, INC.

Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Primary Device ID20682607610031
NIH Device Record Key42f4ae5e-6101-41ea-8890-33b2e0f63985
Commercial Distribution StatusIn Commercial Distribution
Brand NameMission Urinary Tract Infection (UTI) Test strips
Version Model NumberU031-021 2N
Company DUNS781100966
Company NameACON LABORATORIES, INC.
Device Count3
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
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 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100682607003433 [Primary]
GS100682607610037 [Unit of Use]
GS110682607610034 [Package]
Contains: 00682607003433
Package: Inner Pack [6 Units]
In Commercial Distribution
GS120682607610031 [Package]
Contains: 10682607610034
Package: Carton [12 Units]
In Commercial Distribution

FDA Product Code

LJXTEST, URINE LEUKOCYTE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-20
Device Publish Date2025-05-12

Devices Manufactured by ACON LABORATORIES, INC.

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20682607610031 - Mission Urinary Tract Infection (UTI) Test strips2025-05-20
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