FDA.reportPublic FDA data

i-STAT

Primary DI
10054749000187
Brand
i-STAT
Company
ABBOTT POINT OF CARE INC.
Model
03P90-25
Catalog number
03P90-25
Device description
TROPONIN CARTRIDGE
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MMIIMMUNOASSAY METHOD, TROPONIN SUBUNIT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMIImmunoassay Method, Troponin SubunitClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031739000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031739000I-STAT CARDIAC TROPONIN (CTNI) TESTI-Stat Corporation2003-09-02MMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00054749000180PackageGS125In Commercial Distribution
10054749000187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00054749000180000547490001800547490001800054749000180
1005474900018710054749000187

GMDN Terms#

Term, Definition table
TermDefinition
Troponin I IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of troponin I in a clinical specimen.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)366-8020techsvc@apoc.abbott.com

Regulatory Flags#

DUNS number
079226216
Device count
1
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
10054749000200i-STAT03P92-2503P92-252016-09-09
10054749000217i-STAT03P93-2503P93-252016-09-09
10054749000118i-STAT03P83-2503P83-252016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10758750033522VITROSORTHO CLINICAL DIAGNOSTICSMMI2025-12-30
10054749003058i-STAT hs-TnI cartridgeAbbott Point of Care Inc.MMI2025-04-29
00054749003051i-STAT hs-TnI cartridgeAbbott Point of Care Inc.MMI2025-04-29
04987595301803PATHFAST hs-cTnI-IIPHC CORPORATIONMMI2024-05-01
00380740194062AlinityABBOTT IRELANDMMI2022-07-08
00380740194079AlinityABBOTT IRELANDMMI2022-07-08
07613336158951Elecsys Troponin T Gen 5Roche Diagnostics GmbHMMI2022-03-01
07613336158982Elecsys Troponin T Gen 5Roche Diagnostics GmbHMMI2021-09-23
00894175000466RapiCard™ InstaTestDiagnostic Automation, Inc.MMI2021-08-27
00083059070316TROPONIN I (HUMAN CARDIAC-SPECIFIC) ENZYME IMMUNOASSAY TEST KITBIOMERICA, INC.MMI2020-07-01
00630414293783Atellica IM TNIHSiemens Healthcare Diagnostics Inc.MMI2020-05-31
00630414293790Atellica IM TnI-UltraSiemens Healthcare Diagnostics Inc.MMI2020-05-31
00380740175498ARCHITECTABBOTT IRELANDMMI2019-12-03
00380740175504ARCHITECTABBOTT IRELANDMMI2019-12-03
00842768037726Dimension EXL LOCI Troponin I High SensitiveSiemens Healthcare Diagnostics Inc.MMI2019-10-16
00842768037719Dimension Vista Troponin I High SensitiveSiemens Healthcare Diagnostics Inc.MMI2019-08-05
00895160002496Fluoro-CheckTM AMI 3 in 1NANO-DITECH CORPORATIONMMI2019-05-24
00816870020679cTnI AccuBind ELISA Test System - 96 WellsMONOBIND, INC.MMI2019-02-11
00816870020686cTnI AccuBind ELISA Test System - 192 WellsMONOBIND, INC.MMI2019-02-11
00816870022352cTnI AccuLite CLIA Test System - 96 WellsMONOBIND, INC.MMI2019-02-11
00816870022369cTnI AccuLite CLIA Test System - 192 WellsMONOBIND, INC.MMI2019-02-11
30014613337157TriageQUIDEL CARDIOVASCULAR INC.MMI2018-11-01
30014613337164TriageQUIDEL CARDIOVASCULAR INC.MMI2018-11-01
30014613337911TriageQUIDEL CARDIOVASCULAR INC.MMI2018-11-01
30014613337928TriageQUIDEL CARDIOVASCULAR INC.MMI2018-11-01
30014613337935TriageQUIDEL CARDIOVASCULAR INC.MMI2018-11-01
30014613337942TriageQUIDEL CARDIOVASCULAR INC.MMI2018-11-01
30014613337959TriageQUIDEL CARDIOVASCULAR INC.MMI2018-11-01
30014613337966TriageQUIDEL CARDIOVASCULAR INC.MMI2018-11-01
30014613337973TriageQUIDEL CARDIOVASCULAR INC.MMI2018-11-01