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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 030 FR Publication Date: 01/15/2013 

Part B: Supplementary Information

Recognition Number 7-237: CLSI MM01-A3, molecular methods for clinical genetics and oncology testing; approved guideline - third edition. (InVitro Diagnostics)

Date of Standard: 2012. 
Address of Standards Development Organization:
 Clinical Laboratory Standards Institute (CLSI)
  950 West Valley Road
  Suite 2500
  Wayne, PA 19087
 
CDRH Office and Division associated with recognized standards:
OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
Devices Affected:
Qualitative molecular devices for both, acquired and inherited genetic disease testing
Processes Affected:
510(k), PMA, PDP, IDE, HDE
Type of Standard:
 Horizontal, National
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 V Leiden Mutations, Genomic Dna Pcr Class 2 NPQ
FDA Technical Contacts:
 Francisco Martinez-Murillo, Ph.D.
  FDA/CDRH/OIVD
  10903 New Hampshire Avenue Building 66, Room 5551
  Silver Spring MD 20993
  301/796-6201
  email: francisco.martinez@fda.hhs.gov
 Rosalie Elespuru
  FDA/CDRH/OSEL
  10903 New Hampshire Avenue Building 64, Room 3020
  Silver Spring MD 20993
  301/796-0237
  email: rosalie.elespuru@fda.hhs.gov
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