Home GUDID 00819398027069 N/A
Primary DI 00819398027069
Brand N/A
Company HARDY DIAGNOSTICS
Model Z15
Catalog number Z15
Device description Modified Field's Stain Kit, for protozoa such as Acanthamoeba, two 15ml bottles per kitStaining solution for microscopic examination of Protozoa such as Acanthamoeba and Trichomonas spp.Contains:Reagent A (1) 00819398027045Reagent B (1) 00819398027052
Published 2020-08-06
Public version status Update
Distribution status Not 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 00819398027069 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00819398027069 00819398027069 819398027069 0819398027069
GMDN Terms# Term, Definition table Term Definition Biological stain IVD A single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 039981550 Device count 1 Premarket exempt true Kit 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
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