Home GUDID 00816576028849 HardyDisk™
Primary DI 00816576028849
Brand HardyDisk™
Company HARDY DIAGNOSTICS
Model Z7381
Catalog number Z7381
Device description SPS Disks, 1mg, 1 x 50 disks, for identification of Gardnerella vaginalis and P. anaerobius HardyDisk™ SPS Identification Disks evaluate the ability of an organism to grow in the presence of Sodium Polyanethol Sulfonate. HardyDisk™ SPS Identification Disks can be used to presumptively identify microorganisms including but not limited to Peptostreptococcus anaerobius, Gardnerella vaginalis, and Haemophilus ducreyi.
Published 2020-08-10
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 00816576028856 Primary GS1 0 00816576028849 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 00816576028856 00816576028856 816576028856 0816576028856 00816576028849 00816576028849 816576028849 0816576028849
GMDN Terms# Term, Definition table Term Definition Sodium polyanethol sulfonate (SPS) differentiation disc IVD One or multiple diagnostic discs impregnated with sodium polyanethol sulfonate (SPS) test reagents intended to be used in microbial testing for the presumptive identification of Peptostreptococcus anaerobius 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 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 05032384188796 Oxoid™ Bacitracin Diagnostic Discs OXOID LIMITED JTO 2024-07-08 00810144911229 Northeast Laboratory Services Northeast Laboratory Services, Inc. JTO 2023-09-21 00810144911236 Northeast Laboratory Services Northeast Laboratory Services, Inc. JTO 2023-09-21 00810144911243 Northeast Laboratory Services Northeast Laboratory Services, Inc. JTO 2023-09-21 00810144911250 Northeast Laboratory Services Northeast Laboratory Services, Inc. JTO 2023-09-21 00810144911267 Northeast Laboratory Services Northeast Laboratory Services, Inc. JTO 2023-09-21 00810144911274 Northeast Laboratory Services Northeast Laboratory Services, Inc. JTO 2023-09-21 00810144911281 Northeast Laboratory Services Northeast Laboratory Services, Inc. JTO 2023-09-21 00816576029129 HardyDisk™ HARDY DIAGNOSTICS JTO 2023-04-26 00848838023156 REMEL REMEL, INC. JTO 2023-01-03 00848838023194 REMEL REMEL, INC. JTO 2023-01-03 00848838023200 REMEL REMEL, INC. JTO 2023-01-03 00848838023385 REMEL REMEL, INC. JTO 2023-01-03 00848838023392 REMEL REMEL, INC. JTO 2023-01-03 00848838072529 RapID REMEL, INC. JTO 2022-12-23 00848838023729 REMEL REMEL, INC. JTO 2022-12-23 00819398020930 N/A HARDY DIAGNOSTICS JTO 2022-12-07 05032384007189 AN-IDENT DISCSDD6 6X50 DISCS OXOID LIMITED JTO 2022-12-04 05032384034055 X FACTOR OXOID LIMITED JTO 2022-12-04 05032384034079 V FACTOR OXOID LIMITED JTO 2022-12-04 05032384034109 X & V FACTOR OXOID LIMITED JTO 2022-12-04 05032384034130 METRONIDAZOLE 50 DD8 OXOID LIMITED JTO 2022-12-04 05032384034147 SUL SULPHONAMIDE OXOID LIMITED JTO 2022-12-04 05032384034154 ONPG DISCS DD13 OXOID LIMITED JTO 2022-12-04 05032384034178 O129 DISCS (150µG) OXOID LIMITED JTO 2022-12-04 05032384034185 SINGLE CARTRIDGE SPS DISCS DD16 OXOID LIMITED JTO 2022-12-04 05032384104635 X FACTOR OXOID LIMITED JTO 2022-12-04 05032384104659 V FACTOR OXOID LIMITED JTO 2022-12-04 05032384105014 X & V FACTOR OXOID LIMITED JTO 2022-12-04
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