Home GUDID 00816576028474 HardyDisk™
Primary DI 00816576028474
Brand HardyDisk™
Company HARDY DIAGNOSTICS
Model Z7291
Catalog number Z7291
Device description Novobiocin 5ug, NB-5, 1 x 50 disks, for the identification of Staphylococcus saprophyticusUsed to identify Staphylococcus saprophyticus, which is resistant to Novobiocin 5ug (zones less than or equal to 16mm).
Published 2020-08-10
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 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 00816576028474 Primary GS1 0 00816576028467 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 00816576028474 00816576028474 816576028474 0816576028474 00816576028467 00816576028467 816576028467 0816576028467
GMDN Terms# Term, Definition table Term Definition Novobiocin differentiation disc IVD One or multiple diagnostic discs impregnated with the antimicrobial novobiocin intended to be used in microbial testing for the differentiation of coagulase-negative Staphylococcus species 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 50 Premarket exempt true 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 00848838059865 ^BM^ PK/50 OXIDASE TEST REMEL, INC. JTO 2026-01-16 05032384007080 BLANK DISCS OXOID LIMITED JTO 2024-07-11 05032384188796 Oxoid™ Bacitracin Diagnostic Discs OXOID LIMITED JTO 2024-07-08 00816576025121 N/A HARDY DIAGNOSTICS JTO 2024-01-08 00819398021586 N/A HARDY DIAGNOSTICS JTO 2024-01-08 00810144911229 Redipor AnalytiChem USA, Inc. JTO 2023-09-21 00810144911236 Redipor AnalytiChem USA, Inc. JTO 2023-09-21 00810144911243 Redipor AnalytiChem USA, Inc. JTO 2023-09-21 00810144911250 Redipor AnalytiChem USA, Inc. JTO 2023-09-21 00810144911267 Redipor AnalytiChem USA, Inc. JTO 2023-09-21 00810144911274 Redipor AnalytiChem USA, Inc. JTO 2023-09-21 00810144911281 Redipor AnalytiChem USA, Inc. JTO 2023-09-21 00816576029136 HardyDisk™ HARDY DIAGNOSTICS JTO 2023-04-26 00816576029129 HardyDisk™ HARDY DIAGNOSTICS JTO 2023-04-26 00848838002106 REMEL REMEL, INC. JTO 2023-01-03 00848838004131 REMEL REMEL, INC. JTO 2023-01-03 00848838008672 REMEL REMEL, INC. JTO 2023-01-03 00848838022357 REMEL REMEL, INC. JTO 2023-01-03 00848838022395 REMEL REMEL, INC. JTO 2023-01-03 00848838022517 REMEL REMEL, INC. JTO 2023-01-03 00848838022531 REMEL REMEL, INC. JTO 2023-01-03 00848838022579 REMEL REMEL, INC. JTO 2023-01-03 00848838022593 REMEL REMEL, INC. JTO 2023-01-03 00848838022616 REMEL REMEL, INC. JTO 2023-01-03 00848838022630 REMEL REMEL, INC. JTO 2023-01-03 00848838022678 REMEL REMEL, INC. JTO 2023-01-03 00848838022715 REMEL REMEL, INC. JTO 2023-01-03 00848838022746 REMEL REMEL, INC. JTO 2023-01-03 00848838022784 REMEL REMEL, INC. JTO 2023-01-03 00848838022821 REMEL REMEL, INC. JTO 2023-01-03