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510(k) Data Aggregation
K Number
K231806Device Name
Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5
Manufacturer
Oxoid Limited (Part of Thermo Fisher Scientific)
Date Cleared
2024-03-22
(276 days)
Product Code
JTN
Regulation Number
866.1620Why did this record match?
Applicant Name (Manufacturer) :
Oxoid Limited (Part of Thermo Fisher Scientific)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Thermo Scientific Oxoid Antimicrobial Susceptibility Test Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing. Used in a diagnostic workflow to and clinicians in determining potential treatment options for patients suspected of having a microbial infection, these discs are intended to determine susceptibility against microorganisms for which specific drugs have been shown to be active both clinically and in vitro.
The Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 can be used to determine susceptibility to Rezafungin against the following fungi for which Rezafungin has been shown to be active both clinically and in vitro:
Candida albicans
Candida glabrata
Candida parapsilosis
Candida tropicalis
Device Description
Thermo Scientific Oxoid Antimicrobial Susceptibility Test Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing.
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K Number
K232276Device Name
Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20
Manufacturer
Oxoid Limited (Part of Thermo Fisher Scientific)
Date Cleared
2023-10-06
(67 days)
Product Code
JTN
Regulation Number
866.1620Why did this record match?
Applicant Name (Manufacturer) :
Oxoid Limited (Part of Thermo Fisher Scientific)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Thermo Scientific Oxoid Antimicrobial Susceptibility Test Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing. Used in a diagnostic workflow to and clinicians in determining potential treatment options for patients suspected of having a microbial infection, these discs are intended to determine susceptibility against microorganisms for which specific drugs have been shown to be active both clinically and in vitro.
The Thermo Scientific Oxoid Sulbactam Disc (10/10 ug) SUD20 can be used to determine susceptibility to Sulbactam/Durlobactam against the following bacteria for which Sulbactam has been shown to be active both clinically and in vitro:
Acinetobacter-baumannii calcoaceticus complex
Device Description
Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 ug) SUD20
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K Number
K203336Device Name
Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30
Manufacturer
Oxoid Limited (part of Thermo Fisher Scientific)
Date Cleared
2022-09-15
(672 days)
Product Code
JTN
Regulation Number
866.1620Why did this record match?
Applicant Name (Manufacturer) :
Oxoid Limited (part of Thermo Fisher Scientific)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
Not Found
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K Number
K210873Device Name
Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20
Manufacturer
Oxoid Limited (part of Thermo Fisher Scientific)
Date Cleared
2021-10-27
(217 days)
Product Code
JTN
Regulation Number
866.1620Why did this record match?
Applicant Name (Manufacturer) :
Oxoid Limited (part of Thermo Fisher Scientific)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indications for Use (Describe)
Device Description
Not Found
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K Number
K203700Device Name
Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30
Manufacturer
Oxoid Limited (Part of Thermo Fisher Scientific)
Date Cleared
2021-07-30
(224 days)
Product Code
JTN
Regulation Number
866.1620Why did this record match?
Applicant Name (Manufacturer) :
Oxoid Limited (Part of Thermo Fisher Scientific)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Thermo Scientific Oxoid Antimicrobial Susceptibility Test Discs are used in the semi quantitative agar diffusion test method for in vitro susceptibility testing.
The Thermo Scientific Oxoid Cefiderocol Disc (30μg) FDC30 can be used to determine susceptibility to Cefiderocol against the following bacteria for which Cefiderocol has been shown to be active both clinically and in vitro:
For Complicated Urinary Tract Infections (cUTI): Gram-negative bacteria Enterobacter cloacae complex Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruqinosa
For Hospital Acquired Bacterial Pneumonia and ventilator-associated bacterial pneumonia (HABPN VABP):
- Gram-neqative bacteria Enterobacter cloacae complex Escherichia coli Klebsiella pneumoniae Pseudomonas aeruginosa Serratia marcescens
Device Description
Not Found
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K Number
K193508Device Name
Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20
Manufacturer
Oxoid Limited (Part of Thermo Fisher Scientific)
Date Cleared
2020-12-04
(352 days)
Product Code
JTN
Regulation Number
866.1620Why did this record match?
Applicant Name (Manufacturer) :
Oxoid Limited (Part of Thermo Fisher Scientific)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Thermo Scientific Oxoid Antimicrobial Susceptibility Test (AST) Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing.
Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 can be used to determine susceptibility to Eravacycline against the following bacteria for which Eravacycline has been shown to be active both clinically and in vitro: Gram-negative bacteria: Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae
In vitro data are available for the following microorganisms, but clinical significance is unknown: Gram-negative bacteria: Citrobacter koseri Klebsiella aerogenes
Device Description
Not Found
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K Number
K181975Device Name
Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30
Manufacturer
Oxoid Limited (Part of Thermo Fisher Scientific)
Date Cleared
2018-09-27
(65 days)
Product Code
JTN
Regulation Number
866.1620Why did this record match?
Applicant Name (Manufacturer) :
Oxoid Limited (Part of Thermo Fisher Scientific)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Thermo Scientific™ Oxoid™Antimicrobial Susceptibility Test (AST) Discs are used in the semi quantitative agar diffusion test method for in vitro susceptibility testing.
The Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30 can be used to determine susceptibility to Meropenem/Vaborbactam against the following bacteria for which Meropenem/Vaborbactam has been shown to be active both clinically and in vitro:
Escherichia coli
Klebsiella pneumoniae
Enterobacter cloacae species complex
Device Description
Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30μg) MEV30 Antimicrobial Susceptibility Test Discs are 6mm. discs prepared by impregnating high quality absorbent paper with accurately determined amounts of Meropenem and Vaborbactam. The Disc is clearly marked on both sides with the code MEV30. The code designates the agent (Meropenem/Vaborbactam) and the drug content (30µg).
Oxoid discs are supplied in cartridges containing 50 discs each, there are 5 cartridges per pack. Each cartridge is individually sealed together with a desiccant capsule in a foil covered seethrough blister pack. Oxoid discs can be dispensed using an Oxoid Disc Dispenser.
Meropenem/Vaborbactam Disc (30μg) MEV30 Disc Content: Meropenem 20μg / Vaborbactam10μg.
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