FDA.reportPublic FDA data

VITROS

Primary DI
10758750033522
Brand
VITROS
Company
ORTHO CLINICAL DIAGNOSTICS
Model
6912232
Catalog number
6912232
Device description
VITROS Immunodiagnostic Products hs Troponin I Reagent Pack
Published
2025-12-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K252393000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252393000VITROS Immunodiagnostic Products hs Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc.2025-10-29MMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10758750033522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1075875003352210758750033522

GMDN Terms#

Term, Definition table
TermDefinition
Troponin I IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of troponin I in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
215865786
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10758750033287VITROS619773561977352020-05-16
10758750033294VITROS619557561955752020-05-16
10758750032891VITROS690004069000402025-12-30
10758750033539VITROS691223369122332025-12-30
10758750008322VITROS100940610094062020-04-08
10758750002061VITROS680215668021562015-12-22
10758750002504VITROS680230168023012015-12-22
10758750035366VITROS619945461994542025-05-20
10758750035373VITROS619945561994552025-05-20
10758750035380VITROS619945661994562025-05-20
20758750035363VITROS619945461994542025-05-20
20758750035370VITROS619945561994552025-05-20
20758750035387VITROS619945661994562025-05-20
10758750000203VITROS189683618968362016-08-26
10758750002801VITROS680245468024542014-10-22
10758750035465VITROS617444261744422023-11-22
10758750034420VITROS619996161999612021-11-08
10758750033355VITROS619991961999192021-03-22
10758750033362VITROS619992061999202021-03-22
10758750034413VITROS619996061999602021-11-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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00816870022352cTnI AccuLite CLIA Test System - 96 WellsMONOBIND, INC.MMI2019-02-11
00816870022369cTnI AccuLite CLIA Test System - 192 WellsMONOBIND, INC.MMI2019-02-11
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