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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 013 FR Publication Date: 10/31/2005 

Part B: Supplementary Information

Recognition Number 7-123: CLSI MM9-A, nucleic acid sequencing methods in diagnostic laboratory medicine. (InVitro Diagnostics)

Date of Standard: 2004. 
Address of Standards Development Organization:
 Clinical Laboratory Standards Institute (CLSI)
  950 West Valley Road
  Suite 2500
  Wayne, PA 19087
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
DIVISION OF CHEMISTRY AND TOXICOLOGY DEVICES (DCTD)
(2)OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
DIVISION OF IMMUNOLOGY AND HEMATOLOGY DEVICES (DIHD)
(3)OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
DIVISION OF MICROBIOLOGY (DMD)
(4)OFFICE OF COMPLIANCE (OC)
Devices Affected:
Molecular genetics and genomics devices using sequencing methods or using sequencing as the reference method for validation
Processes Affected:
510(k), PMA, PDP, IDE, HDE
Type of Standard:
 National, Horizontal
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
Unclassified Assay,Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus Class 3 MZP
§862.3360 Drug Metabolizing Enzyme Genotyping Systems Class 2 NTI
§864.7280 Test, Factor Ii G20210a Mutations, Genomic Dna Pcr Class 2 NPR
§864.7280 Test, Factor V Leiden Mutations, Genomic Dna Pcr Class 2 NPQ
FDA Technical Contact:
 Sharon (Xueying) Liang
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5266
  Silver Spring MD 20993
  301/796-9601
  email: sharon.liang@fda.hhs.gov
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