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Mastocytosis / Clinical research / Pharmaceutical industry / Tryptase / Clinical and Laboratory Standards Institute / Validation / Allergy / Food and Drug Administration / Mast cell / Biology / Health / Anatomy


Attachment E CDRH Final Guidance Cover Sheet
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City

Rockville / Lyon / /

Company

LARC Press / In Vitro Diagnostics / HP / Radiological / /

Continent

North America / Europe / /

/

Event

FDA Phase / /

Facility

Laboratory Standards Institute / /

IndustryTerm

tryptase test system devices / tryptase test system device / tryptase test systems / predicate device / marketed predicate device / marketed device / /

MedicalCondition

established mastocytosis / Tumors / inflammatory processes / myeloid neoplasms / anaphylaxis / hematologic clonal non-mast cell lineage disease-type disease / chronic and acute symptoms / pruritic rash / inflammatory mediators / systemic mastocytosis / allergic reactions / mastocytosis / systemic mast cell disease / heterogeneous clonal disorder / tumours / /

Organization

Radiological Health Office / U.S. Department of Health and Human Services / World Health Organization / Division of Immunology and Hematology Devices / Food and Drug Administration / Center for Devices and Radiological Health / Division of Dockets Management / Radiological Health Division of Immunology and Hematology Devices Preface Public Comment You / Food and Drug Administration Center for Devices / Clinical and Laboratory Standards Institute / /

Person

Elizabeth Stafford / /

/

Position

Governor / /

Product

EP5-A2 / EP17-A / Evaluation / /

ProvinceOrState

Maryland / /

PublishedMedium

Baseline / /

RadioStation

Clin N Am 26 / /

Technology

antibodies / User Protocol / /

URL

http /

SocialTag