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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 025 FR Publication Date: 10/04/2010 

Part B: Supplementary Information

Recognition Number 7-213: CLSI H18-A4, procedures for the handling and processing of blood specimens for common laboratory tests; approved guideline-fourth edition. (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 Offices and Divisions associated with recognized standards:
(1)OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
(2)OFFICE OF COMPLIANCE (OC)
Devices Affected:
Chemistry, Hematology
Processes Affected:
510(k), PMA, PDP
Type of Standard:
 National, Horizontal
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§862.1675 Tray, Blood Collection Class 2 GJE
§862.1675 Tubes, Vacuum Sample, With Anticoagulant Class 2 GIM
§862.1675 Tubes, Vials, Systems, Serum Separators, Blood Collection Class 2 JKA
§864.3250 Container, Specimen Mailer And Storage, Sterile Class 1 KDT
§864.3250 Container, Specimen Mailer And Storage, Temperature Controlled, Sterile Class 1 KDW
§864.3250 Container, Specimen, Sterile Class 1 FMH
FDA Technical Contact:
 Yung Chan
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5630
  Silver Spring MD 20993
  301/796-6138
  email: yung.chan@fda.hhs.gov
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