Device classification

Glucose-6-Phosphate Dehydrogenase (Erythrocytic), U.V. Kinetic

Hematology · 21 CFR 864.7360

Class IIProduct code JBK
Open FDA's page for this record
Third party flag
Y
Life sustain support flag
N
Gmp exempt flag
N
Summary malfunction reporting
Eligible
Product code
JBK
Review panel
HE
Medical specialty
HE
Device name
Glucose-6-Phosphate Dehydrogenase (Erythrocytic), U.V. Kinetic
Medical specialty description
Hematology
Device class
2
Regulation number
864.7360
Implant flag
N
Submission type ID
1
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.