Home GUDID 20816101025583 Simplexa™ C. difficile Universal Direct
Primary DI 20816101025583
Brand Simplexa™ C. difficile Universal Direct
Company DIASORIN MOLECULAR LLC
Model MOL2975
Catalog number MOL2975
Published 2016-09-22
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name OMN C. Difficile Nucleic Acid Amplification Test Assay
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OMN C. Difficile Nucleic Acid Amplification Test Assay Microbiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20816101025583 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20816101025583 20816101025583
GMDN Terms# Term, Definition table Term Definition Clostridium difficile 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, including specific gene markers from Clostridium difficile bacteria in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT). Markers detected may include genes conferring antimicrobial resistance (e.g., gyrA gene), virulence (e.g., ribotype 027) and genes encoding toxin A and/or B.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature -30 Degrees Celsius -10 Degrees Celsius
Regulatory Flags# DUNS number 080271715 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 20816101020243 Rickettsia IFA IgG IF0100G IF0100G 2026-03-13 20816101020250 Rickettsia IFA IgM IF0100M IF0100M 2026-03-13 20816101020342 Q Fever IFA IgG IF0200G IF0200G 2026-03-13 20816101020359 Q Fever IFA IgM IF0200M IF0200M 2026-03-13 20816101020397 Arbovirus IFA IgG IF0300G IF0300G 2026-03-13 20816101020403 Arbovirus IFA IgM IF0300M IF0300M 2026-03-13 20816101025538 Simplexa™ Flu A/B & RSV MOL2600 MOL2600 2016-09-22 20816101025507 Simplexa™ HSV 1 & 2 Direct MOL2150 MOL2150 2016-09-22 20816101025514 Simplexa™ HSV 1 & 2 Positive Control Pack MOL2160 MOL2160 2016-09-22 10816101025142 LIAISON NES® Instrument NES1001 NES1001 2026-01-22 10816101025159 LIAISON NES® Instrument (Refurbished) NES1001R NES1001R 2026-01-22 20816101029031 LIAISON NES® FLU A/B, RSV & COVID-19 NES4450 NES4450 2026-01-22 20816101029048 LIAISON NES® FLU A/B, RSV & COVID-19 Control Swab Kit NES4460 NES4460 2026-01-22 20816101027358 Simplexa COVID-19 / Flu A/B & RSV Direct MOL4450 MOL4450 2026-01-14 20816101027365 Simplexa COVID-19 / Flu A/B & RSV Positive Control Pack MOL4460 MOL4460 2026-01-14 10816101020772 R. rickettsii Substrate Slide IF0102 IF0102 2025-12-16 10816101027375 Blastomyces Primer Pair MOL9206 MOL9206 2025-12-16 20816101027136 Simplexa COVID-19 Positive Control GEN II Pack MOL4165 MOL4165 2025-09-17 10816101025005 Integrated Cyler (110V) MOL1001 MOL1001 2016-09-24 10816101025012 Integrated Cyler (110V) Pre-Owned MOL1001-P MOL1001-P 2016-09-24
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840733102134 Alethia™ C. difficile External Control Kit MERIDIAN BIOSCIENCE, INC. OMN 2019-01-09 00840733102172 Alethia™ C. difficile MERIDIAN BIOSCIENCE, INC. OMN 2019-01-09 07332940000028 Xpert C. difficile/Epi CEPHEID OMN 2018-01-29 07332940000042 Xpert C. difficile/Epi CEPHEID OMN 2018-01-29 00840733101120 illumigene C. difficile External Control Kit MERIDIAN BIOSCIENCE, INC. OMN 2016-09-23 00840733101168 illumigene C. difficile MERIDIAN BIOSCIENCE, INC. OMN 2016-09-23 B178GBCDIFF100 Portrait Toxigenic C. difficile Assay GREAT BASIN SCIENTIFIC, INC. OMN 2016-09-23
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