i-STAT

GUDID 00054749005154

i-Stat 1 Wireless Analyzer

ABBOTT POINT OF CARE INC.

Multichannel clinical chemistry analyser IVD, point-of-care, battery-powered
Primary Device ID00054749005154
NIH Device Record Key1eca5632-52e2-4cde-bcf5-ccb70fc205ab
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-STAT
Version Model Number03P75-83
Company DUNS079226216
Company NameABBOTT POINT OF CARE INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com
Phone+1(800)366-8020
Emailtechsvc@apoc.abbott.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius
Handling Environment TemperatureBetween 16 Degrees Celsius and 46 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100054749005154 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CGAGlucose Oxidase, Glucose
OWDSomatic gene mutation detection system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-09
Device Publish Date2020-07-01

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00054749003914i-STAT 1 Analyzer, Immuno Ready
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00054749003891i-STAT 1 Analyzer, Immuno Ready
00054749003884i-STAT 1 Analyzer, Immuno Ready
00054749003877i-STAT 1 Analyzer, Immuno Ready
00054749003860i-STAT 1 Analyzer, Immuno Ready
00054749003853i-STAT 1 Analyzer, Immuno Ready
00054749003846i-Stat 1 Wireless Analyzer
00054749003839i-Stat 1 Wireless Analyzer
00054749003822i-Stat 1 Wireless Analyzer
00054749003815i-Stat 1 Wireless Analyzer
00054749003808i-Stat 1 Wireless Analyzer
00054749003792i-Stat 1 Wireless Analyzer
00054749003785i-Stat 1 Wireless Analyzer
00054749003778i-STAT 1 Analyzer, Immuno Ready
00054749003761i-STAT 1 Analyzer, Immuno Ready
00054749003754i-STAT 1 Analyzer, Immuno Ready
00054749003747i-STAT 1 Analyzer, Immuno Ready
00054749003730i-STAT 1 Analyzer, Immuno Ready
00054749003723i-STAT 1 Analyzer, Immuno Ready
00054749003716i-STAT 1 Analyzer, Immuno Ready
00054749003709i-STAT 1 Analyzer, Immuno Ready
00054749003693i-STAT 1 Analyzer, Immuno Ready
00054749003600i-STAT 1 Analyzer, Immuno Ready
00054749003587i-Stat 1 Wireless Analyzer
00054749003402i-Stat 1 Wireless Analyzer
00054749003396i-Stat 1 Wireless Analyzer
00054749003389i-Stat 1 Wireless Analyzer
00054749003372i-Stat 1 Wireless Analyzer
00054749003365i-Stat 1 Wireless Analyzer
00054749003358i-Stat 1 Wireless Analyzer
00054749003044i-Stat 1 Wireless Analyzer
00054749002528i-Stat 1 Wireless Analyzer
00054749001408i-Stat 1 Wireless Analyzer
00054749001262MILITARY KIT
00054749001248i-STAT ACT, CONTROL LEVEL 2
00054749001231i-STAT ACT, CONTROL LEVEL 1
00054749001224i-STAT PT, CONTROL LEVEL 2
00054749001217i-STAT PT, CONTROL LEVEL 1
00054749000340i-STAT 1 Analyzer, Immuno Ready
00054749005093i-STAT 1 Wireless
00054749005512Cartridge, Chem8+
00054749005529i-STAT 1 Wireless
00054749005222i-Stat 1 Wireless Analyzer
00054749005215i-Stat 1 Wireless Analyzer
00054749005208i-Stat 1 Wireless Analyzer
00054749005192i-Stat 1 Wireless Analyzer
00054749005185i-Stat 1 Wireless Analyzer
00054749005178i-Stat 1 Wireless Analyzer
00054749005161i-Stat 1 Wireless Analyzer

Trademark Results [i-STAT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
I-STAT
I-STAT
77298232 3577397 Dead/Cancelled
ICS BUILDING TECHNOLOGIES
2007-10-08
I-STAT
I-STAT
75171521 2177858 Live/Registered
ABBOTT POINT OF CARE INC.
1996-09-18
I-STAT
I-STAT
75171518 2196980 Live/Registered
ABBOTT POINT OF CARE INC.
1996-09-18
I-STAT
I-STAT
74665634 2085232 Live/Registered
ABBOTT POINT OF CARE INC.
1995-04-25
I-STAT
I-STAT
74057416 1879156 Live/Registered
I-STAT CORPORATION
1990-05-07
I-STAT
I-STAT
73789592 not registered Dead/Abandoned
INTERNATIONAL CARDIOVASCULAR MEDICINE, INC.
1989-03-27
I-STAT
I-STAT
73728329 1538585 Dead/Cancelled
I-STAT CORPORATION
1988-05-04
I-STAT
I-STAT
73007703 1002688 Live/Registered
CONCEPT, INC.
1973-11-30

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