FDA.reportPublic FDA data

Audit MicroControls Control FD Assayed Chemistry Level 1

Primary DI
B085K0311100
Brand
Audit MicroControls Control FD Assayed Chemistry Level 1
Company
AALTO SCIENTIFIC
Model
K0311-10
Published
2018-03-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B085K0311100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-type clinical chemistry analyte profile 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 multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.

Regulatory Flags#

DUNS number
077974989
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B085K084M60Audit MicroControls Control LQ Cystatin CK084M-62026-08-27
B085K0312100Audit MicroControls Control FD Assayed Chemistry Level 2K0312-102018-03-27
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
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