Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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029
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Date of Entry 08/20/2012
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FR Recognition Number
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7-76
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Standard | |
CLSI M15-A (Replaces M15-T) Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline |
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Scope/AbstractThis document contains guidelines for specimen collection, blood film preparation, and staining procedures. Recommendations for optimum timing of specimen collection to assist laboratories in detecting, identifying and reporting certain parasites are also included. |
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Extent of Recognition
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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 Contact
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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. |