Home GUDID 20816101025620 Simplexa™ Bordetella Direct
Primary DI 20816101025620
Brand Simplexa™ Bordetella Direct
Company DIASORIN MOLECULAR LLC
Model MOL2750
Catalog number MOL2750
Device description Simplexa™ Bordetella Direct
Published 2018-08-24
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name OZZ Bordetella Pertussis Dna Assay System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OZZ Bordetella Pertussis Dna Assay System Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20816101025620 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20816101025620 20816101025620
GMDN Terms# Term, Definition table Term Definition Multiple respiratory 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 multiple bacteria associated with respiratory disease in a clinical specimen, using a nucleic acid technique (NAT). Organisms detected may include (but are not limited to) Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, Chlamydophila psittaci, C. pneumoniae (Chlamydia pneumoniae), Coxiella burnetii, Legionella pneumophila and/or Bordetella pertussis.
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 00875197007350 cobas liat Bordetella panel nucleic acid test Roche Molecular Systems, Inc. OZZ 2026-02-23 00875197007367 cobas liat Bordetella panel control kit Roche Molecular Systems, Inc. OZZ 2026-02-23 00815381020390 BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel BIOFIRE DIAGNOSTICS, LLC OZZ 2024-05-03 00815381020659 BIOFIRE ® SPOTFIRE ® Respiratory (R) Panel BIOFIRE DIAGNOSTICS, LLC OZZ 2023-04-06 30014613336167 Solana DIAGNOSTIC HYBRIDS, INC. OZZ 2020-02-04 00851034007073 BioCode Respiratory Pathogen Panel APPLIED BIOCODE, INC. OZZ 2020-01-10 00840487101612 Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge LUMINEX CORPORATION OZZ 2019-12-05 00840487101667 Respiratory Pathogens Flex (RP Flex) Extraction Tray LUMINEX CORPORATION OZZ 2019-12-05 00840487101711 Respiratory Pathogens Flex (RP Flex) Amplification Tray LUMINEX CORPORATION OZZ 2019-12-05 04053228033905 QIAstat-Dx® Respiratory Panel QIAGEN GmbH OZZ 2019-05-24 00840733102141 Alethia™ Pertussis External Control Kit MERIDIAN BIOSCIENCE, INC. OZZ 2019-01-08 00840733102226 Alethia™ Pertussis MERIDIAN BIOSCIENCE, INC. OZZ 2019-01-08 20816101025637 Simplexa™ Bordetella Positive Control Pack DIASORIN MOLECULAR LLC OZZ 2018-08-24 00815381020154 FilmArray® Respiratory Panel 2 (RP2) BIOFIRE DIAGNOSTICS, LLC OZZ 2017-07-18 00815381020161 FilmArray® Respiratory Panel 2 (RP2) BIOFIRE DIAGNOSTICS, LLC OZZ 2017-07-18 B178GBBORD100 Bordetella Direct Test GREAT BASIN SCIENTIFIC, INC. OZZ 2017-07-12 00840487101452 ARIES® Bordetella Assay LUMINEX CORPORATION OZZ 2017-05-09 00815381020147 FilmArray® Respiratory Panel (RP) EZ BIOFIRE DIAGNOSTICS, LLC OZZ 2016-12-06 00840733101137 illumigene Pertussis External Control Kit MERIDIAN BIOSCIENCE, INC. OZZ 2016-09-23 00840733101199 illumigene Pertussis MERIDIAN BIOSCIENCE, INC. OZZ 2016-09-23 00857573006164 Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge NANOSPHERE, INC. OZZ 2016-09-23 00857573006263 Respiratory Pathogens Flex (RP Flex) Extraction Tray NANOSPHERE, INC. OZZ 2016-09-23 00857573006324 Respiratory Pathogens Flex (RP Flex) Amplification Tray NANOSPHERE, INC. OZZ 2016-09-23 00815381020062 FilmArray® Respiratory Panel (RP) BIOFIRE DIAGNOSTICS, LLC OZZ 2016-09-23 00815381020079 FilmArray® Respiratory Panel (RP) BIOFIRE DIAGNOSTICS, LLC OZZ 2016-09-23 30014613312093 AmpliVue QUIDEL CORPORATION OZZ 2016-09-15
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