Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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050
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Date of Entry 09/17/2018
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FR Recognition Number
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7-275
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Standard | |
CLSI EP07 3rd Edition Interference Testing in Clinical Chemistry. |
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Scope/AbstractThis guideline is intended for manufacturers and medical laboratories. EP07 assists manufacturers and other developers of laboratory measurement procedures in characterizing the effects of potential interferents on measurement procedures results. EP07 also contains background information on interference testing concepts |
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Extent of Recognition
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES |
HEMATOLOGY AND PATHOLOGY DEVICES |
IMMUNOLOGY AND MICROBIOLOGY DEVICES |
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Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contacts
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |