Home GUDID 00819398026550 N/A
Primary DI 00819398026550
Brand N/A
Company HARDY DIAGNOSTICS
Model Z54
Catalog number Z54
Device description Rapid Urea Medium, useful for Helicobacter pylori, 2ml, 15x45mm tube, 10 per box Rapid Urea Medium for rapid detection of urease activity in Helicobacter pylori, Cryptococcus neoformans, or Proteus spp. Biopsy specimen from endoscopy can be submerged into the agar, positive reactions (pink-red color) may be noted within minutes.
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 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 00819398026567 Primary GS1 0 00819398026550 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 00819398026567 00819398026567 819398026567 0819398026567 00819398026550 00819398026550 819398026550 0819398026550
GMDN Terms# Term, Definition table Term Definition Differential/selective broth culture medium IVD A broth culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing in the same medium. It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation.
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 10 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 00810144911007 Northeast Laboratory Services Northeast Laboratory Services, Inc. JSF 2023-12-08 00810144910994 Northeast Laboratory Services Northeast Laboratory Services, Inc. JSF 2023-09-21 00810144911014 Northeast Laboratory Services Northeast Laboratory Services, Inc. JSF 2023-09-21 00810144911021 Northeast Laboratory Services Northeast Laboratory Services, Inc. JSF 2023-09-21 00810144911038 Northeast Laboratory Services Northeast Laboratory Services, Inc. JSF 2023-09-21 00810144911045 Northeast Laboratory Services Northeast Laboratory Services, Inc. JSF 2023-09-21 00810144911052 Northeast Laboratory Services Northeast Laboratory Services, Inc. JSF 2023-09-21 00810144911069 Northeast Laboratory Services Northeast Laboratory Services, Inc. JSF 2023-09-21 00848838023606 REMEL REMEL, INC. JSF 2022-12-27 00848838010545 REMEL REMEL, INC. JSF 2022-12-27 00848838010576 REMEL REMEL, INC. JSF 2022-12-27 00848838010590 REMEL REMEL, INC. JSF 2022-12-27 00848838010606 REMEL REMEL, INC. JSF 2022-12-27 00848838011085 REMEL REMEL, INC. JSF 2022-12-27 00848838013539 REMEL REMEL, INC. JSF 2022-12-27 00848838008788 REMEL REMEL, INC. JSF 2022-12-27 00848838010460 REMEL REMEL, INC. JSF 2022-12-27 00848838011665 REMEL REMEL, INC. JSF 2022-12-27 00848838009426 REMEL REMEL, INC. JSF 2022-12-27 00848838008238 REMEL REMEL, INC. JSF 2022-12-23 00848838007989 REMEL REMEL, INC. JSF 2022-12-23 00848838007996 REMEL REMEL, INC. JSF 2022-12-23 00848838007736 REMEL REMEL, INC. JSF 2022-12-23 00848838006807 REMEL REMEL, INC. JSF 2022-12-23 00848838007545 REMEL REMEL, INC. JSF 2022-12-23 00848838005824 REMEL REMEL, INC. JSF 2022-12-23 00848838011917 REMEL REMEL, INC. JSF 2022-12-23 00848838005787 REMEL REMEL, INC. JSF 2022-12-23 00848838005879 REMEL REMEL, INC. JSF 2022-12-23 00819398024778 N/A HARDY DIAGNOSTICS JSF 2020-06-09
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