Home GUDID 00819398026772 LanaGram™
Primary DI 00819398026772
Brand LanaGram™
Company HARDY DIAGNOSTICS
Model Z49
Catalog number Z49
Device description LanaGram™, rapid color test for bacterial gram reaction, 15 tests per packageFor organisms that are difficult to gram stain. Uses the aminopeptidase reaction. LanaGram™ confirms the gram stain reaction of gram-negative and gram-positive aerobic or facultatively anaerobic rods or coccobacilli. This test is not recommended for use with gram-positive cocci, microaerophilic or obligate anaerobic organisms.
Published 2020-06-16
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 JSF Culture Media, Single Biochemical Test
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JSF Culture Media, Single Biochemical Test Microbiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00819398026772 Primary GS1 0 00819398026765 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 00819398026772 00819398026772 819398026772 0819398026772 00819398026765 00819398026765 819398026765 0819398026765
GMDN Terms# Term, Definition table Term Definition Gram stain IVD, reagent A substance or reactant intended to be used together with a parent IVD to perform a specific function in a Gram stain (also referred to as Brown and Benn or Brown-Hopps stain), that is used for the demonstration and differentiation of bacteria in biological/clinical specimens.
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 15 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 00810144911007 Redipor AnalytiChem USA, Inc. JSF 2023-12-08 00810144910994 Redipor AnalytiChem USA, Inc. JSF 2023-09-21 00810144911014 Redipor AnalytiChem USA, Inc. JSF 2023-09-21 00810144911021 Redipor AnalytiChem USA, Inc. JSF 2023-09-21 00810144911038 Redipor AnalytiChem USA, Inc. JSF 2023-09-21 00810144911045 Redipor AnalytiChem USA, Inc. JSF 2023-09-21 00810144911052 Redipor AnalytiChem USA, Inc. JSF 2023-09-21 00810144911069 Redipor AnalytiChem USA, Inc. JSF 2023-09-21 00848838002625 REMEL REMEL, INC. JSF 2022-12-27 00848838008405 REMEL REMEL, INC. JSF 2022-12-27 00848838008412 REMEL REMEL, INC. JSF 2022-12-27 00848838008429 REMEL REMEL, INC. JSF 2022-12-27 00848838008474 REMEL REMEL, INC. JSF 2022-12-27 00848838008498 REMEL REMEL, INC. JSF 2022-12-27 00848838008504 REMEL REMEL, INC. JSF 2022-12-27 00848838008511 REMEL REMEL, INC. JSF 2022-12-27 00848838008573 REMEL REMEL, INC. JSF 2022-12-27 00848838008597 REMEL REMEL, INC. JSF 2022-12-27 00848838008658 REMEL REMEL, INC. JSF 2022-12-27 00848838008719 REMEL REMEL, INC. JSF 2022-12-27 00848838008757 REMEL REMEL, INC. JSF 2022-12-27 00848838008771 REMEL REMEL, INC. JSF 2022-12-27 00848838008801 REMEL REMEL, INC. JSF 2022-12-27 00848838008856 REMEL REMEL, INC. JSF 2022-12-27 00848838008863 REMEL REMEL, INC. JSF 2022-12-27 00848838008870 REMEL REMEL, INC. JSF 2022-12-27 00848838008894 REMEL REMEL, INC. JSF 2022-12-27 00848838008917 REMEL REMEL, INC. JSF 2022-12-27 00848838008955 REMEL REMEL, INC. JSF 2022-12-27 00848838008962 REMEL REMEL, INC. JSF 2022-12-27
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