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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 7-182: CLSI M36-A, clinical use and interpretation of serologic tests for toxoplasma gondii. (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 Office and Division associated with recognized standards:
OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
DIVISION OF MICROBIOLOGY (DMD)
Devices Affected:
Toxoplasma gondii Serologic devices
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
§866.3780 Antigens, Cf, Toxoplasma Gondii Class 2 GMN
§866.3780 Antigens, If, Toxoplasma Gondii Class 2 GLZ
§866.3780 Antigens, Iha, Toxoplasma Gondii Class 2 GMM
§866.3780 Antisera, If, Toxoplasma Gondii Class 2 LJK
§866.3780 Direct Agglutination Test, Toxoplasma Gondii Class 2 LLA
§866.3780 Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii Class 2 LGD
§866.3780 Pneumocystis Carinii Class 2 LYF
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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