FDA.reportPublic FDA data

ETEST®

Primary DI
03573026623562
Brand
ETEST®
Company
BIOMERIEUX SA
Model
ETEST®
Device description
ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria
Published
2021-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
03573026623562PackageGS110In Commercial Distribution
03573026623838PrimaryGS10
03573026624101Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026623562035730266235623573026623562
03573026623838035730266238383573026623838
03573026624101035730266241013573026624101

GMDN Terms#

Term, Definition table
TermDefinition
Antifungal minimum inhibitory concentration (MIC) IVDA graduated test strip or collection of reagents containing a specified concentration gradient of a specific antifungal/antimycotic (i.e., a drug intended for treatment and/or prevention of a fungal infection) 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 Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
276816717
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
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
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
03573026548889Etest® FLUCONAZOLEBIOMERIEUX SANGZ2016-11-18
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