Home GUDID 03573026048617 RAPID 20 E™
Primary DI 03573026048617
Brand RAPID 20 E™
Company BIOMERIEUX SA
Model RAPID 20 E™
Device description 4-hour ID of Enterobacteriaceae. API®strips give accurate ID based on extensive databases and are standardized, easy-to-use test systems.
Published 2020-04-10
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 JSS KIT, IDENTIFICATION, ENTEROBACTERIACEAE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JSS Kit, Identification, Enterobacteriaceae Microbiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 03573026048617 Package GS1 25 In Commercial Distribution 03573026588526 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 03573026048617 03573026048617 3573026048617 03573026588526 03573026588526 3573026588526
GMDN Terms# Term, Definition table Term Definition Multiple gram negative bacteria species culture isolate identification IVD, kit A collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of gram negative bacteria belonging to the Enterobacteriaceae or non-Enterobacteriaceae families, that have been isolated by culture from a clinical specimen.
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 1 DM exempt false Premarket exempt true 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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