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

CFR - Code of Federal Regulations Title 21

  • Print
  • Share
  • E-mail
-

The information on this page is current as of Mar 22, 2024.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

New Search
Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[CITE: 21CFR864.7360]
See Related Information on Erythrocytic glucose-6-phosphate dehydrogenase assay. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES

PART 864 -- HEMATOLOGY AND PATHOLOGY DEVICES

Subpart H - Hematology Kits and Packages

Sec. 864.7360 Erythrocytic glucose-6-phosphate dehydrogenase assay.

(a) Identification. An erythrocytic glucose-6-phosphate dehydrogenase assay is a device used to measure the activity of the enzyme glucose-6-phosphate dehydrogenase or of glucose-6-phosphate dehydrogenase isoenzymes. The results of this assay are used in the diagnosis and treatment of nonspherocytic congenital hemolytic anemia or drug-induced hemolytic anemia associated with a glucose-6-phosphate dehydrogenase deficiency. This generic device includes assays based on fluorescence, electrophoresis, methemoglobin reduction, catalase inhibition, and ultraviolet kinetics.

(b) Classification. Class II (performance standards).

[45 FR 60616, Sept. 12, 1980]

-
-