Home GUDID 03573026359096 VITEK® MS-DS
Primary DI 03573026359096
Brand VITEK® MS-DS
Company BIOMERIEUX SA
Model VITEK® MS-DS
Device description The VITEK MS-DS target slides enable the identification of microorganisms according to the MALDI-TOF mass spectrometry method.
Published 2016-12-23
Public version status Update
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 PEX System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PEX System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 03573026359096 Package GS1 8 In Commercial Distribution 03573026554224 Primary GS1 0 03573026554217 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 03573026359096 03573026359096 3573026359096 03573026554224 03573026554224 3573026554224 03573026554217 03573026554217 3573026554217
GMDN Terms# Term, Definition table Term Definition Microbial identification mass spectrometry system IVD An assembly of mains electricity (AC-powered) devices intended to be used for the qualitative detection and identification of microbial species (bacteria, fungi) in a clinical specimen using mass spectrometry. It typically consists of a sample handling/preparation unit, a mass spectrometry instrument, and a server with software intended to analyse results and compare the produced spectra with information in a remote database to identify and report the microbial species in the specimen. The system operates with reduced technician involvement and automation of some, but not all, procedural steps.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 15 Degrees Celsius 25 Degrees Celsius
Regulatory Flags# DUNS number 276816717 Device count 4 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
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