Home GUDID 00819398027557 HardyDisk™
Primary DI 00819398027557
Brand HardyDisk™
Company HARDY DIAGNOSTICS
Model Z118
Catalog number Z118
Device description Caffeic Acid Disks, for Cryptococcus, 25 disks per pack HardyDisk™ Caffeic Acid Disks detect the ability of an organism to produce the enzyme phenyloxidase, which is useful for the identification of Cryptococcus neoformans and Cryptococcus gattii.
Published 2020-07-09
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 00819398028578 Primary GS1 0 00819398027557 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 00819398028578 00819398028578 819398028578 0819398028578 00819398027557 00819398027557 819398027557 0819398027557
GMDN Terms# Term, Definition table Term Definition Multiple meningitis pathogen nucleic acid IVD, reagent A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay intended to be used for the qualitative and/or quantitative detection nucleic acid from multiple types of microorganisms associated with meningitis, in a clinical specimen. Microorganisms detected may include but are not limited to Streptococcus meningitidis, Neisseria meningitidis, Haemophilus influenzae, Cryptococcus neoformans, adenovirus, enterovirus, cytomegalovirus (CMV), Epstein-Barr virus (EBV), herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2), varicella-zoster virus (VZV), and Mumps virus.
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 25 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 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
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