Home GUDID 00816576028252 HardyDisk™
Primary DI 00816576028252
Brand HardyDisk™
Company HARDY DIAGNOSTICS
Model Z7015
Catalog number Z7015
Device description Optochin, HardyDisk™, for the differentiation of alpha-hemolytic Streptococcus pneumoniae, 50 disks per cartridge, 5 each For use in the presumptive identification of Streptococcus pneumoniae from other alpha-hemolytic streptococci.
Published 2020-08-07
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 JTO Discs, Strips And Reagents, Microorganism Differentiation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816576028269 Primary GS1 0 00816576028276 Primary GS1 0 00816576028252 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 00816576028269 00816576028269 816576028269 0816576028269 00816576028276 00816576028276 816576028276 0816576028276 00816576028252 00816576028252 816576028252 0816576028252
GMDN Terms# Term, Definition table Term Definition Optochin/ethylhydrocupreine differentiation disc IVD One or multiple diagnostic discs impregnated with optochin reagent, also known as ethylhydrocupreine, intended to be used in microbial testing for the differentiation of Streptococcus pneumoniae bacteria isolated from a clinical specimen by culture.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature -20 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 039981550 Device count 250 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00848838059865 ^BM^ PK/50 OXIDASE TEST REMEL, INC. JTO 2026-01-16 05032384188796 Oxoid™ Bacitracin Diagnostic Discs OXOID LIMITED JTO 2024-07-08 00810144911229 Northeast Laboratory Services Northeast Laboratory Services, Inc. JTO 2023-09-21 00810144911236 Northeast Laboratory Services Northeast Laboratory Services, Inc. JTO 2023-09-21 00810144911243 Northeast Laboratory Services Northeast Laboratory Services, Inc. JTO 2023-09-21 00810144911250 Northeast Laboratory Services Northeast Laboratory Services, Inc. JTO 2023-09-21 00810144911267 Northeast Laboratory Services Northeast Laboratory Services, Inc. JTO 2023-09-21 00810144911274 Northeast Laboratory Services Northeast Laboratory Services, Inc. JTO 2023-09-21 00810144911281 Northeast Laboratory Services Northeast Laboratory Services, Inc. JTO 2023-09-21 00816576029129 HardyDisk™ HARDY DIAGNOSTICS JTO 2023-04-26 00848838023156 REMEL REMEL, INC. JTO 2023-01-03 00848838023194 REMEL REMEL, INC. JTO 2023-01-03 00848838023200 REMEL REMEL, INC. JTO 2023-01-03 00848838023385 REMEL REMEL, INC. JTO 2023-01-03 00848838023392 REMEL REMEL, INC. JTO 2023-01-03 00848838072529 RapID REMEL, INC. JTO 2022-12-23 00848838023729 REMEL REMEL, INC. JTO 2022-12-23 00819398020930 N/A HARDY DIAGNOSTICS JTO 2022-12-07 05032384007189 AN-IDENT DISCSDD6 6X50 DISCS OXOID LIMITED JTO 2022-12-04 05032384034055 X FACTOR OXOID LIMITED JTO 2022-12-04 05032384034079 V FACTOR OXOID LIMITED JTO 2022-12-04 05032384034109 X & V FACTOR OXOID LIMITED JTO 2022-12-04 05032384034130 METRONIDAZOLE 50 DD8 OXOID LIMITED JTO 2022-12-04 05032384034147 SUL SULPHONAMIDE OXOID LIMITED JTO 2022-12-04 05032384034154 ONPG DISCS DD13 OXOID LIMITED JTO 2022-12-04 05032384034178 O129 DISCS (150µG) OXOID LIMITED JTO 2022-12-04 05032384034185 SINGLE CARTRIDGE SPS DISCS DD16 OXOID LIMITED JTO 2022-12-04 05032384104635 X FACTOR OXOID LIMITED JTO 2022-12-04 05032384104659 V FACTOR OXOID LIMITED JTO 2022-12-04 05032384105014 X & V FACTOR OXOID LIMITED JTO 2022-12-04
hardydiagnostics.com