Home GUDID 03573026619671 ETEST®
Primary DI 03573026619671
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 2021-07-13
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 Code Name LTX DISCS, ELUTION
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LTX Discs, Elution Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 03573026619671 Package GS1 10 In Commercial Distribution 03573026620110 Primary GS1 0 03573026620516 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 03573026619671 03573026619671 3573026619671 03573026620110 03573026620110 3573026620110 03573026620516 03573026620516 3573026620516
GMDN Terms# Term, Definition table Term Definition Antibacterial minimum inhibitory concentration (MIC) IVD A graduated test strip or collection of reagents containing a specified concentration gradient of a specific antibiotic (i.e., a drug intended for treatment and/or prevention of a bacterial infection, excluding mycobacterial 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 Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
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 DI Brand Model Catalog Published 03573026064532 VIDAS® Measles IgG 30219 2019-08-30 03573026064518 VIDAS® Varicella-Zoster IgG 30217 2016-08-31 03573026610418 VITEK®MS VITEKMS SW v1.0 / FlexPrep v1.0 2019-04-30 03573026644796 VIDAS® Varicella-Zoster IgG 30217-01 2026-01-19 03573026550523 ETEST® Tigecycline (TGC) Etest® TIGECYCLINE 2016-12-12 03573026584139 ID color Catalase ID color Catalase 2019-07-19 03573026092009 ID color Catalase ID color Catalase 2019-07-19 03573026559823 THxID™ BRAF 1.0 2017-05-12 03573026121631 VIDAS® Quality Control 30706 2019-11-19 B0744000160 ASTUTE140 Electronic Quality Control (EQC) Device 400016 400016 2016-08-12 B0745000090 NEPHROCHECK Calibration Verification (Cal Vers) Kit 500009 500009 2016-08-12 B0745000110 NEPHROCHECK Test Kit 500011 500011 2016-08-12 B0745000130 NEPHROCHECK Liquid Control Kit 500013 500013 2016-08-12 03573026547226 ETEST® Ertapenem (ETP) ETEST® Ertapenem (ETP) 2016-11-18 03573026547271 ETEST® Tobramycin (TM) ETEST® Tobramycin (TM) 2016-11-18 03573026547295 ETEST® Tigecycline (TGC) ETEST® Tigecycline (TGC) 2016-11-18 03573026548674 ETEST® Ampicillin/sulbactam (2/1) (AB) ETEST® Ampicillin/sulbactam (2/1) (AB) 2016-11-18 03573026549046 ETEST® Tetracycline (TC) ETEST® Tetracycline (TC) 2016-11-18 03573026549077 ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS) ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS) 2016-11-18 03573026547196 ETEST® Fosfomycin (FM) ETEST® Fosfomycin (FM) 2016-11-18
Other Devices Sharing Product Codes#