FDA.reportPublic FDA data

Audit MicroControls Linearity FLQ Troponin T for Roche Systems

Primary DI
B085K932M50
Brand
Audit MicroControls Linearity FLQ Troponin T for Roche Systems
Company
AALTO SCIENTIFIC
Model
K932M-5
Published
2020-11-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B085K932M50PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Troponin T IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of Troponin T in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
077974989
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B085K907M50Audit MicroControls Linearity LQ CRP for Ortho VitrosK907M-52022-08-30
B085K819M50Audit MicroControls Linearity FLQ Anemia for Siemens AtellicaK819M-52020-05-05
B085K801M50Audit MicroControls Linearity LQ Homocysteine Siemens AtellicaK801M-52018-03-27
B085K804M50Audit MicroControls Linearity FD Cardiac Markers for Siemens AtellicaK804M-52018-03-27
B085K834M50Audit MicroControls Linearity FD ProcalcitoninK834M-52018-06-22
B085K841M50Audit MicroControls Linearity FD Procalcitonin for bioMerieux VIDASK841M-52018-03-27
B085K845M50Audit MicroControls Linearity FD D-Dimer for bioMerieux VIDASK845M-52019-02-14
B085K962M100Audit MicroControls Linearity FD Thryoid for Ortho VitrosK962M-102026-05-15
B085K726M50Audit MicroControls Linearity LQ ISEK726M-52018-03-27
B085K745M50Audit MicroControls Linearity LQ OsmolalityK745M-52026-04-30
B085K905M50Audit MicroControls Linearity LQ Direct TIBC for Ortho VitrosK905M-52019-01-02
B085K083M80Audit MicroControls Control FD Traumatic Brain Injury (TBI)K083M-82026-03-25
B085K924M100Audit MicroControls Linearity FD Tumor Markers for Roche SystemsK924M-102025-12-18
B085K895M50Audit MicroControls Control LQ Galectin-3K895M-52019-01-02
B085K087M60Audit MicroControls Control LQ COVID-19 IgG + IgM AntibodiesK087M-62020-11-12
B085K908M50Audit MicroControls Linearity FLQ Cardiac Markers for Ortho VitrosK908M-52023-06-15
B085K936M50Audit MicroControls Linearity FLQ Cardiac Markers for Roche SystemsK936M-52023-06-15
B085K919M50Audit MicroControls Linearity FLQ General Chemistry Panel 3 for Roche SystemsK919M-52023-06-06
B085K701MSUPP0Audit MicroControls Linearity FD Bilirubin SupplementK701M-SUPP2022-07-12
B085K983M50Audit MicroControls Linearity FLQ HbA1c for Bio-Rad SystemsK983M-52022-03-08