FDA.reportPublic FDA data

ASTUTE140 Electronic Quality Control (EQC) Device

Primary DI
B0744000160
Brand
ASTUTE140 Electronic Quality Control (EQC) Device
Company
BIOMERIEUX SA
Model
400016
Catalog number
400016
Published
2016-08-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PIGAcute Kidney Injury Test System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PIGAcute Kidney Injury Test SystemClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B0744000160PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Fluorescent immunoassay analyser IVD, laboratory, semi-automatedA stationary mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen. The instrument detects fluorescent markers that result from an immunological reaction between the reagents and the specimen, and typically includes an autosampler, reagent dispenser, light source, filter or monochromator, a fluorescent detection system (fluorometer or spectrofluorometer), data processing and/or data display software. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
276816717
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03573026064532VIDAS® Measles IgG302192019-08-30
03573026064518VIDAS® Varicella-Zoster IgG302172016-08-31
03573026610418VITEK®MSVITEKMS SW v1.0 / FlexPrep v1.02019-04-30
03573026644796VIDAS® Varicella-Zoster IgG30217-012026-01-19
03573026550523ETEST® Tigecycline (TGC)Etest® TIGECYCLINE2016-12-12
03573026584139ID color CatalaseID color Catalase2019-07-19
03573026092009ID color CatalaseID color Catalase2019-07-19
03573026559823THxID™ BRAF1.02017-05-12
03573026121631VIDAS® Quality Control307062019-11-19
B0745000090NEPHROCHECK Calibration Verification (Cal Vers) Kit5000095000092016-08-12
B0745000110NEPHROCHECK Test Kit 5000115000112016-08-12
B0745000130NEPHROCHECK Liquid Control Kit5000135000132016-08-12
03573026547226ETEST® Ertapenem (ETP)ETEST® Ertapenem (ETP)2016-11-18
03573026547271ETEST® Tobramycin (TM)ETEST® Tobramycin (TM)2016-11-18
03573026547295ETEST® Tigecycline (TGC)ETEST® Tigecycline (TGC)2016-11-18
03573026548674ETEST® Ampicillin/sulbactam (2/1) (AB)ETEST® Ampicillin/sulbactam (2/1) (AB)2016-11-18
03573026549046ETEST® Tetracycline (TC)ETEST® Tetracycline (TC)2016-11-18
03573026549077ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS)ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS)2016-11-18
03573026547196ETEST® Fosfomycin (FM)ETEST® Fosfomycin (FM)2016-11-18
03573026547509ETEST® Ceftaroline (CPT)ETEST® Ceftaroline (CPT)2016-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05711435000156ProNephro AKI™ (NGAL) Reagent KitBioporto Diagnostics A/SPIG2025-08-28
05711435000248ProNephro AKI™ (NGAL) Reagent Kit Bioporto Diagnostics A/SPIG2024-08-02
05711435000255ProNephro AKI™ (NGAL) Calibrator KitBioporto Diagnostics A/SPIG2024-08-02
05711435000262ProNephro AKI™ (NGAL) Control KitBioporto Diagnostics A/SPIG2024-08-02
03573026616038VIDAS® NEPHROCHECK®BIOMERIEUX SAPIG2023-03-13
B0745000090NEPHROCHECK Calibration Verification (Cal Vers) KitBIOMERIEUX SAPIG2016-08-12
B0745000110NEPHROCHECK Test Kit BIOMERIEUX SAPIG2016-08-12
B0745000130NEPHROCHECK Liquid Control KitBIOMERIEUX SAPIG2016-08-12
B0745000170ASTUTE140 Meter KitBIOMERIEUX SAPIG2016-08-12