[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR862.1117]

[Page 187]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES--Table of Contents
 
               Subpart B--Clinical Chemistry Test Systems
 
Sec. 862.1117  B-type natriuretic peptide test system.

    (a) Identification. The B-type natriuretic peptide (BNP) test system 
is an in vitro diagnostic device intended to measure BNP in whole blood 
and plasma. Measurements of BNP are used as an aid in the diagnosis of 
patients with congestive heart failure.
    (b) Classification. Class II (special controls). The special control 
is ``Class II Special Control Guidance Document for B-Type Natriuretic 
Peptide Premarket Notifications; Final Guidance for Industry and FDA 
Reviewers.''

[66 FR 12734, Feb. 28, 2001]