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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 021 FR Publication Date: 03/18/2009 

Part B: Supplementary Information

Recognition Number 7-180: CLSI M34-A, western blot assay for antibodies to borrelia burgdorferi. (InVitro Diagnostics)

Date of Standard: 2000. 
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)
(2)OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Borrelia burgdorferi antibody test reagents regulated under 21 CFR 866.3830 with product code LSR; Reagent, Borrelia Serological Reagent
Processes Affected:
510(k), Pre-IDE
Type of Standard:
 Horizontal, National
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§866.3830 Reagent, Borrelia Serological Reagent Class 2 LSR
FDA Technical Contact:
 Prasad Rao
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5508
  Silver Spring MD 20993
  301/796-6203
  email: prasad.rao@fda.hhs.gov
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