FDA.reportPublic FDA data

i-STAT PTplus Cartridge

Primary DI
00054749004782
Brand
i-STAT PTplus Cartridge
Company
Abbott Point of Care Inc.
Model
03P89-50
Catalog number
03P89-50
Device description
For the determination ofprothrombin time.
Published
2024-01-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GJSTEST, TIME, PROTHROMBIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GJSTest, Time, ProthrombinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220282000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220282000i-STAT PTplus Cartridge with the i-STAT 1 SystemAbbott Laboratories2023-07-14GJS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00054749004782PrimaryGS10
10054749004789Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00054749004782000547490047820547490047820054749004782
1005474900478910054749004789

GMDN Terms#

Term, Definition table
TermDefinition
Prothrombin time (PT) IVD, kit, clottingA collection of reagents and other associated materials intended to be used for the quantitative measurement of the prothrombin time (PT) of a clinical specimen, with or without standardization to the international normalized ratio (INR), using a clotting method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1-888-366-8020techsvc@apoc.abbott.com

Regulatory Flags#

DUNS number
116279183
Device count
25
HCT/P
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10054749005519i-STAT09P31-2609P31-262020-05-01
10054749000163i-STAT03P88-2503P88-252016-09-09
10054749000132i-STAT03P85-2503P85-252016-09-09
00054749004027i-STAT06F24-2006F24-202023-09-22
00054749001385i-STAT06F24-1606F24-162023-06-23
00054749004911i-STAT hs-TnI Calibration Verification, Levels 1-306P17-2006P17-202025-05-02
00054749004928i-STAT hs-TnI Control Level 106P17-2106P17-212025-05-02
00054749004935i-STAT hs-TnI Control Level 206P17-2206P17-222025-05-02
00054749004942i-STAT hs-TnI Control Level 306P17-2306P17-232025-05-02
10054749003058i-STAT hs-TnI cartridge09P81-2509P81-252025-04-29
00054749003051i-STAT hs-TnI cartridge09P81-2509P81-252025-04-29
10054749005779i-STAT TBI cartridge03S09-2503S09-252024-07-08
00054749005772i-STAT TBI cartridge03S09-2503S09-252024-07-08
00054749000661i-STAT06F14-0106F14-012023-06-23
10054749000071i-STAT03P79-2503P79-252016-09-09
10054749000149i-STAT03P86-2503P86-252016-09-09
10054749000170i-STAT03P89-2403P89-242016-09-09
10054749000187i-STAT03P90-2503P90-252016-09-09
10054749000200i-STAT03P92-2503P92-252016-09-09
10054749000217i-STAT03P93-2503P93-252016-09-09

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Primary DI, Brand, Company table
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09360136000086 Xprecia Prime™ Coagulation AnalyzerUNIVERSAL BIOSENSORS PTY LTDGJS2024-08-27
09360136000093Xprecia Prime™ PT/INR Test StripsUNIVERSAL BIOSENSORS PTY LTDGJS2024-08-27
08436540291134microINR ® Link KitILINE MICROSYSTEMS SLGJS2024-08-02
08436540290915microINR ® Link KitILINE MICROSYSTEMS SLGJS2024-08-02
00850053916205IDG/SanzayIDG/SANZAY CorporationGJS2024-07-03
08436540290908microINR ® Link KitILINE MICROSYSTEMS SLGJS2024-04-01
00630414639871Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00630414639888Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00630414639963Thromborel SSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00630414640006Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
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00842768019609Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00842768018749Thromborel SSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00842768019586Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00850053916182IDG/SanzayIDG/SANZAY CorporationGJS2024-01-12
00054749004843i-STAT PTplus Control Level 1Abbott Point of Care Inc.GJS2024-01-10
00054749004850i-STAT PTplus Control Level2Abbott Point of Care Inc.GJS2024-01-10
00365702702356CoaguChek VantusRoche Diagnostics GmbHGJS2023-12-01
00850040656022Assure PT Care PT/INR Monitoring System COAGUSENSE INC.GJS2023-04-06
00850040656039Assure PT Care Test Strip KitCOAGUSENSE INC.GJS2023-04-06
00860007370861Coag-senseCOAGUSENSE INC.GJS2021-09-30
00860007370878Coag-senseCOAGUSENSE INC.GJS2021-09-30
00861900000398Coag-Sense Test Strip Kit, 50 ct.COAGUSENSE INC.GJS2021-09-09
10861900000395Coag-Sense Test Strip Kit, 50 ct.COAGUSENSE INC.GJS2021-09-09
08436540290717microINR ® CHIPS ILINE MICROSYSTEMS SLGJS2021-05-28
08436540290816microINR ® MeterILINE MICROSYSTEMS SLGJS2021-05-28
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