Home GUDID 00816576026838 HardyCHROM™
Primary DI 00816576026838
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
Rx false
OTC false
Sterile false
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 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# 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 00816576026845 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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