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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 7-220: CLSI H59-A, quantitative d-dimer for the exclusion of venous thromboembolic disease; approved guideline. (InVitro Diagnostics)

Date of Standard: 2011. 
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 DEVICE EVALUATION (ODE)
DIVISION OF CARDIOVASCULAR DEVICES (DCD)
(2)OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
DIVISION OF IMMUNOLOGY AND HEMATOLOGY DEVICES (DIHD)
Devices Affected:
Any medical devices measuring d-dimer to exclude
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Design Control Input, Quality System Regulation
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete standard with the following exceptions:

Section 9.4 is not recognized

Table A 1 is not recognized
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§864.7320 Fibrin Split Products Class 2 GHH
§864.7320 Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control Class 2 DAP
Relevant Guidance:
There is no relevant guideline developed at this time.
FDA Technical Contact:
 Lea Carrington
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 4224
  Silver Spring MD 20993
  301/796-6164
  email: lea.carrington@fda.hhs.gov
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