FDA.reportPublic FDA data

Audit MicroControls Linearity FD BNP (High)

Primary DI
B085K713M50
Brand
Audit MicroControls Linearity FD BNP (High)
Company
AALTO SCIENTIFIC
Model
K713M-5
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
B085K713M50PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide 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 B-type natriuretic protein (BNP) and/or N-terminal pro b-type natriuretic peptide (NT-proBNP) 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
Primary DIBrandModelCatalogPublished
B085K924M100Audit MicroControls Linearity FD Tumor Markers for Roche SystemsK924M-102025-12-18
B085K087M60Audit MicroControls Control LQ COVID-19 IgG + IgM AntibodiesK087M-62020-11-12
B085K932M50Audit MicroControls Linearity FLQ Troponin T for Roche SystemsK932M-52020-11-03
B085K815M50Audit MicroControls Linearity FD ISE for Siemens AtellicaK815M-52025-11-26
B085K939M100Audit MicroControls Linearity FD Tumor Markers for Abbott SystemsK939M-102025-11-26
B085K743M50Audit MicroControls Linearity FD Lipoprotein (a)K743M-52025-11-20
B085K829M100Audit MicroControls Linearity FD Urine Chemistry for Beckman AUK829M-102025-11-20
B085K922M50Audit MicroControls Linearity FLQ Special Diabetes for Roche SystemsK922M-52024-12-16
B085K836M50Audit MicroControls Linearity FD BNP for Abbott SystemsK836M-52025-07-22
B085K830M50Audit MicroControls Linearity LQ Ammonia/Alcohol for Ortho VitrosK830M-52025-07-10
B085K762M50Audit MicroControls Linearity LQ Special ProteinsK762M-52025-04-28
B085K739M100Audit MicroControls Linearity FD Traumatic Brain Injury (TBI)K739M-102025-04-10
B085K742M50Audit MicroControls Linearity FD BilirubinK742M-52025-04-10
B085K864M50Audit MicroControls Linearity FD General Chemistry Panel 1 for Alfa WassermannK864M-52025-03-06
B085K865M50Audit MicroControls Linearity FD General Chemistry Panel 2 for Alfa WassermannK865M-52025-03-06
B085K866M50Audit MicroControls Linearity FD General Chemistry Panel 3 for Alfa WassermannK866M-52025-03-06
B085K867M100Audit MicroControls Linearity FD General Chemistry Panel 4 for Alfa WassermannK867M-102025-03-06
B085K061M60Audit MicroControls Control FD HbA1cK061M-62018-03-27
B085K852M200Audit MicroControls Method Val FD UCH-L1 for bioMérieux VIDAS® TBI (UCH-L1)K852M-202025-01-06
B085K846M100Audit MicroControls Linearity FD GFAP, UCH-L1 for bioMérieux VIDAS® TBI (GFAP, UK846M-102024-12-06