FDA.reportPublic FDA data

Etest® FLUCONAZOLE

Primary DI
03573026548889
Brand
Etest® FLUCONAZOLE
Company
BIOMERIEUX SA
Model
Etest® FLUCONAZOLE
Device description
Etest is a quantitative technique for determining susceptibility of clinically significant yeast. It provides a gradient of 15 doubling dilutions for MIC determination.
Published
2016-11-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NGZSusceptibility Test Plate, Antifungal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGZSusceptibility Test Plate, AntifungalMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040560000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040560000ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTINGAb Biodisk2004-07-27NGZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026252861PackageGS1100Not in Commercial Distribution
03573026548889PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026252861035730262528613573026252861
03573026548889035730265488893573026548889

GMDN Terms#

Term, Definition table
TermDefinition
Fluconazole minimum inhibitory concentration (MIC) IVDA graduated test strip or collection of reagents containing a specified concentration gradient of the antimicrobial fluconazole, intended to be used to determine the minimum inhibitory concentration (MIC) for a particular microorganism, isolated from a clinical specimen by culture.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius22 Degrees Celsius

Regulatory Flags#

DUNS number
276816717
Device count
1
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
B0744000160ASTUTE140 Electronic Quality Control (EQC) Device4000164000162016-08-12
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05032384571413SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDNGZ2024-07-25
05032384571451SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDNGZ2024-07-25
05032384503513SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDNGZ2024-07-25
05032384474561SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDNGZ2024-07-25
05032384571611SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDNGZ2024-07-24
05032384571789SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDNGZ2024-07-24
05032384571321SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDNGZ2024-07-24
05032384511419SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDNGZ2024-07-24
00848838036835SENSITITRE YEASTONE SUSCEPTIBILITY PLATESREMEL, INC.NGZ2023-06-20
03573026623838ETEST® Fluconazole (FL)BIOMERIEUX SANGZ2021-12-03
03573026623562ETEST®BIOMERIEUX SANGZ2021-12-03
03573026550363ETEST® Itraconazole (IT)BIOMERIEUX SANGZ2019-10-22
03573026616014Etest® ITRACONAZOLEBIOMERIEUX SANGZ2019-10-22
03573026619350VITEK® 2 AST-YS09BIOMERIEUX , INC.NGZ2019-04-05
03573026619268VITEK 2 ® AST-YS09BIOMERIEUX , INC.NGZ2019-04-05
03573026529758VITEK® 2 AST-YS05BIOMERIEUX , INC.NGZ2017-01-09
03573026373047VITEK® 2 AST-YS05BIOMERIEUX , INC.NGZ2017-01-09
03573026550158ETEST® Fluconazole (FL)BIOMERIEUX SANGZ2016-12-12
03573026550165ETEST® Flucytosine (FC)BIOMERIEUX SANGZ2016-12-12
03573026550516ETEST® Voriconazole (VO)BIOMERIEUX SANGZ2016-12-12
03573026377731ETEST® Flucytosine (FC)BIOMERIEUX SANGZ2016-12-12
03573026377717Etest® FLUCONAZOLEBIOMERIEUX SANGZ2016-12-12
03573026378974Etest® VORICONAZOLEBIOMERIEUX SANGZ2016-12-12
03573026548896ETEST® Flucytosine (FC)BIOMERIEUX SANGZ2016-11-18
03573026549091Etest® ITRACONAZOLEBIOMERIEUX SANGZ2016-11-18
03573026253318Etest® ITRACONAZOLEBIOMERIEUX SANGZ2016-11-18
03573026252885Etest® FLUCYTOSINEBIOMERIEUX SANGZ2016-11-18
M578YO2IVD2SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDNGZ2016-09-24
M578YO3IVD2SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDNGZ2016-09-24
00848838018817NAREMEL, INC.NGZ2016-09-24