• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Recognition List Number: 021 FR Publication Date: 03/18/2009 

Part B: Supplementary Information

Recognition Number 7-191: CLSI MM13-A, collection, transport, preparation, and storage of specimens for molecular methods; approved guideline. (InVitro Diagnostics)

Date of Standard: 2005. 
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:
All specimen collection kits and transport media used for preparation, storage and transporting of human specimens to a laboratory test site.
Processes Affected:
510(k), PMA, 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
§866.2360 Culture Media, Selective Broth Class 1 JSD
§866.2390 Culture Media, Anaerobic Transport Class 1 JSL
§866.2390 Culture Media, Non-Propagating Transport Class 1 JSM
§866.2900 Device, Parasite Concentration Class 1 LKS
§866.2900 Device, Specimen Collection Class 1 LIO
§866.2900 System, Transport, Aerobic Class 1 JTW
§866.2900 Transport Systems, Anaerobic Class 1 JTX
FDA Technical Contact:
 Laura Jaeger
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5545
  Silver Spring MD 20993
  301/796-5937
  email: laura.jaeger@fda.hhs.gov
-
-