FDA.reportPublic FDA data

Audit MicroControls Control FD Glycohemoglobin A1c

Primary DI
B085K061M80
Brand
Audit MicroControls Control FD Glycohemoglobin A1c
Company
AALTO SCIENTIFIC
Model
K061M-8
Published
2018-03-27
Public version status
New
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
B085K061M80PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Glycated haemoglobin (HbA1c) 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 glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin, in a clinical specimen.

Sterilization Methods#

Method table
Method

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
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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