Home GUDID 00816576026845 HardyCHROM™
Primary DI 00816576026845
Brand HardyCHROM™
Company HARDY DIAGNOSTICS
Model J28
Catalog number J28
Device description HardyCHROM™ CRE/ HardyCHROM™ ESBL, 15x100mm Biplate, 10ml/10ml. HardyCHROM™ CRE is a selective and differential chromogenic medium intended for the qualitative and presumptive detection from stool, rectal swabs, and related specimens of Escherichia coli that are non-susceptible to carbapenems as pink colonies and KES that are non-susceptible to carbapenems as blue colonies.HardyCHROM™ ESBL s a selective and differential chromogenic medium that is intended for the qualitative and presumptive detection from stool specimens of 1) Enterobacterales that are potentially non-susceptible to ceftazidime and cefpodoxime; and 2) Extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli, Klebsiella pneumoniae , and Klebsiella oxytoca.
Published 2023-12-08
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816576026845 Primary GS1 0 00816576026838 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00816576026845 00816576026845 816576026845 0816576026845 00816576026838 00816576026838 816576026838 0816576026838
GMDN Terms# Term, Definition table Term Definition Multiple formulation agar culture medium IVD A combination of two or more selective, differential and/or enriched agar culture media formulations separately contained within a single petri dish (commonly referred to as a split plate) or dip slide and intended to be used for the simultaneous growth, selective isolation and/or differentiation of microorganisms 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 039981550 Device count 10 Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10382902154218 BD BBL™ CHROMagar™ MRSA II / CHROMagar™ SA BECTON, DICKINSON AND COMPANY JSO 2024-08-22 30382902154212 BD BBL™ CHROMagar™ MRSA II / CHROMagar™ SA BECTON, DICKINSON AND COMPANY JSO 2024-08-22 00816576026838 HardyCHROM™ HARDY DIAGNOSTICS JSO 2023-12-08 00848838085628 SPECTRA REMEL, INC. JSO 2022-12-22 00848838085635 SPECTRA REMEL, INC. JSO 2022-12-22 00816576026807 HardyCHROM HARDY DIAGNOSTICS JSO 2020-05-20 00816576025770 HardyCHROM™ HARDY DIAGNOSTICS JSO 2019-10-21 03573026597719 CHROMID® CARBA agar BIOMERIEUX SA JSO 2018-09-28 03573026409913 CHROMID® CARBA agar BIOMERIEUX SA JSO 2018-09-28 03610521536208 Select BIO-RAD JSO 2018-02-09 03610521536215 Select BIO-RAD JSO 2018-02-09 00816576023097 HardyCHROM™ HARDY DIAGNOSTICS JSO 2017-03-28 10382902152283 BD BBL™ CHROMagar® MRSA II BECTON, DICKINSON AND COMPANY JSO 2016-12-23 30382902152287 BD BBL™ CHROMagar® MRSA II BECTON, DICKINSON AND COMPANY JSO 2016-12-23 10382902152290 BD BBL™ CHROMagar® MRSA II BECTON, DICKINSON AND COMPANY JSO 2016-12-21 10382902212406 BD BBL™ GC II Agar with IsoVitaleX™ Enrichment BECTON, DICKINSON AND COMPANY JSO 2016-12-21 10382902219542 BD BBL™ Haemophilus Test Medium Agar (HTM Agar) BECTON, DICKINSON AND COMPANY JSO 2016-12-21 30382902212400 BD BBL™ GC II Agar with IsoVitaleX™ Enrichment BECTON, DICKINSON AND COMPANY JSO 2016-12-21 30382902152294 BD BBL™ CHROMagar® MRSA II BECTON, DICKINSON AND COMPANY JSO 2016-12-21 30382902219546 BD BBL™ Haemophilus Test Medium Agar (HTM Agar) BECTON, DICKINSON AND COMPANY JSO 2016-12-21 10382902153594 BD BBL™ CHROMagar™ MRSA II / CHROMagar™ SA BECTON, DICKINSON AND COMPANY JSO 2016-12-16 30382902153598 BD BBL™ CHROMagar™ MRSA II / CHROMagar™ SA BECTON, DICKINSON AND COMPANY JSO 2016-12-16 00848838004216 NA REMEL, INC. JSO 2016-12-09 05032384002924 NA OXOID LIMITED JSO 2016-09-24 05032384003150 NA OXOID LIMITED JSO 2016-09-24 05032384003174 NA OXOID LIMITED JSO 2016-09-24 05032384003181 NA OXOID LIMITED JSO 2016-09-24 05032384003198 NA OXOID LIMITED JSO 2016-09-24 00848838000522 NA REMEL, INC. JSO 2016-09-24 00848838000546 NA REMEL, INC. JSO 2016-09-24
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