Precision Xtra 99838

GUDID 30093815998380

Precision Xtra Blood Glucose Test Strips

ABBOTT DIABETES CARE INC

Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care
Primary Device ID30093815998380
NIH Device Record Key98e5305a-7ec2-42e0-8551-c48f62bed690
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrecision Xtra
Version Model Number99838
Catalog Number99838
Company DUNS966390890
Company NameABBOTT DIABETES CARE INC
Device Count50
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)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100093815998389 [Primary]
GS110093815998386 [Unit of Use]
GS130093815998380 [Package]
Contains: 00093815998389
Package: Case [12 Units]
In Commercial Distribution
NDC/NHRIC57599-9838-4 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFRGlucose dehydrogenase, glucose

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-12-11
Device Publish Date2016-07-22

On-Brand Devices [Precision Xtra]

30093815998786Precision Xtra Blood Glucose Test Strips
30093815998779Precision Xtra Blood Glucose Test Strips
30093815998380Precision Xtra Blood Glucose Test Strips
30093815998373Precision Xtra Blood Glucose & Ketone Monitoring System
40093815997281Precision Xtra Blood Glucose Test Strips
30093815996959Precision Xtra Blood Glucose Test Strips
30093815996942Precision Xtra Blood Glucose Test Strips
30093815988145Precision Xtra Blood Glucose & Ketone Monitoring System
30093815800508Precision Xtra Blood Glucose Test Strips
30093815715024Precision Xtra Blood Glucose & Ketone Monitoring System
30093815707463Precision Xtra Blood ß-Ketone Test Strips
30093815707456Precision Xtra Blood ß-Ketone Test Strips

Trademark Results [Precision Xtra]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PRECISION XTRA
PRECISION XTRA
77952020 3935672 Live/Registered
Abbott Laboratories
2010-03-05
PRECISION XTRA
PRECISION XTRA
77065423 3293222 Live/Registered
Abbott Laboratories
2006-12-15

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