FDA.reportPublic FDA data

Audit MicroControls Linearity LQ Ammonia/Ethanol for Roche Systems

Primary DI
B085K881M50
Brand
Audit MicroControls Linearity LQ Ammonia/Ethanol for Roche Systems
Company
AALTO SCIENTIFIC
Model
K881M-5
Published
2018-03-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B085K881M50PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyte IVD, controlA material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple clinical chemistry analytes, and which together may create a full general biochemistry profile.

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
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
B085K801M50Audit MicroControls Linearity LQ Homocysteine Siemens Atellica/CentaurK801M-52018-03-27
B085K845M50Audit MicroControls Linearity FD D-Dimer bioMerieux VIDASK845M-52019-02-14
B085K895M50Audit MicroControls Control LQ Galectin-3K895M-52019-01-02
B085K087M60Audit MicroControls Control LQ COVID-19 IgG + IgM AntibodiesK087M-62020-11-12
B085K932M50Audit MicroControls Linearity FLQ Troponin T for Roche SystemsK932M-52020-11-03
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
B085K918M50Audit MicroControls Linearity FLQ General Chemistry Panel 2 for Roche SystemsK918M-52022-03-02
B085K980M50Audit MicroControls Linearity FLQ Active B12K980M-52022-03-02
B085K086M60Audit MicroControls Control FD COVID-19 Antigen – NucleocapsidK086M-62022-02-04
B085K917M50Audit MicroControls Linearity FLQ General Chemistry Panel 1 for Roche SystemsK917M-52022-01-11