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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 7-190: CLSI M50-A, quality control for commercial microbial identification systems. (InVitro Diagnostics)

Date of Standard: 2008. 
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:
Microbial Identification system
Processes Affected:
Pre-IDE, 510(k), 510(k) exempt
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§866.2660 Gram Positive Identification Panel Class 1 LQL
§866.2660 Instrument For Auto Reader Of Overnight Microorganism Identification System Class 1 LRH
FDA Technical Contact:
 Marieann Brill
  FDA/CDRH/OIVD
  2098 Gaither Road, HFZ-440
  Rockville MD 20850
  240/276-0726
  email: marieann.brill@fda.hhs.gov
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