Home GUDID 15420045506350 PRODESSE
Primary DI 15420045506350
Brand PRODESSE
Company Hologic, Inc.
Model PROGASTRO SSCS ASSAY
Catalog number 303278
Published 2016-04-15
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 LLH REAGENTS, CLOSTRIDIUM DIFFICILE TOXIN
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LLH Reagents, Clostridium Difficile Toxin Microbiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 15420045506350 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 15420045506350 15420045506350
GMDN Terms# Term, Definition table Term Definition Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or more bacteria associated with gastrointestinal diseases, in a clinical specimen, using a nucleic acid technique (NAT). Bacteria detected may include Salmonella, Shigella, Campylobacter, Escherichia coli (E. coli), Bacillus and/or Vibrio species.
Regulatory Flags# DUNS number 050579217 Device count 1 DM 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 08033891322779 CHORUS CLIA CLOSTRIDIUM DIFFICILE A/B TOXINS DIESSE DIAGNOSTICA SENESE SPA LLH 2025-08-19 05032384519828 ProSpecT™ Wash Buffer OXOID LIMITED LLH 2024-07-05 05032384519903 ProSpecT C. difficile Toxin A/B Microplate OXOID LIMITED LLH 2022-12-23 06974849369229 Clostridium Difficile Glutamate Dehydrogenase(GDH) and Toxin A/B Detection Kit ( Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. LLH 2022-12-06 06974849369236 Clostridium Difficile Glutamate Dehydrogenase(GDH) and Toxin A/B Detection Kit ( Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. LLH 2022-12-06 00848838027093 Remel REMEL, INC. LLH 2022-04-21 00848838068416 Remel REMEL, INC. LLH 2022-04-21 30848838027094 Remel REMEL, INC. LLH 2022-04-21 30848838068417 Remel REMEL, INC. LLH 2022-04-21 00857031002646 C. DIFFICILE TOX A/B II TECHLAB, INC. LLH 2021-05-07 00857031002660 C. DIFF CHEK - 60 TECHLAB, INC. LLH 2021-05-03 00840733101786 ImmunoCard Toxins A & B MERIDIAN BIOSCIENCE, INC. LLH 2020-09-21 00840733101694 PREMIER Toxins A and B MERIDIAN BIOSCIENCE, INC. LLH 2020-09-01 00857031002066 C. DIFFICILE TOXIN ANTITOXIN KIT TECHLAB, INC. LLH 2020-01-24 00857031002073 C. DIFFICILE TOX-B TEST TECHLAB, INC. LLH 2020-01-24 00857031002264 C. DIFFICILE TOX-B TEST TECHLAB, INC. LLH 2020-01-24 03573026229146 VIDAS® C. difficile Toxin A & B BIOMERIEUX SA LLH 2019-11-08 00857031002431 C. DIFFICILE TOX A/B II TECHLAB, INC. LLH 2019-05-31 00857031002448 C. DIFF CHEK - 60 TECHLAB, INC. LLH 2019-05-31 00857031002554 C. DIFF QUIK CHEK COMPLETE TECHLAB, INC. LLH 2019-05-31 00857031002110 C. DIFF CHEK - 60 TECHLAB, INC. LLH 2019-04-12 00857031002219 C. DIFFICILE TOX A/B II TECHLAB, INC. LLH 2019-04-12 00857031002226 C. DIFF CHEK - 60 TECHLAB, INC. LLH 2019-04-12 00857031002103 C. DIFFICILE TOX A/B II TECHLAB, INC. LLH 2018-10-31 00857031002233 C. DIFF CHEK - 60 TECHLAB, INC. LLH 2018-10-31 00857031002424 C. DIFFICILE TOX A/B II TECHLAB, INC. LLH 2018-09-28 00857031002042 TOX A/B QUIK CHEK TECHLAB, INC. LLH 2018-08-07 00857031002059 C. DIFF QUIK CHEK COMPLETE TECHLAB, INC. LLH 2018-08-07 00857031002158 C. DIFF QUIK CHEK COMPLETE TECHLAB, INC. LLH 2018-08-07 00857031002257 TOX A/B QUIK CHEK TECHLAB, INC. LLH 2018-08-07