Device classification

Turbidimetric Method, Globulin

Clinical Chemistry · 21 CFR 862.1330

Class IProduct code JGEExempt
Open FDA's page for this record
Third party flag
N
Life sustain support flag
N
Gmp exempt flag
N
Summary malfunction reporting
Eligible
Product code
JGE
Review panel
CH
Medical specialty
CH
Device name
Turbidimetric Method, Globulin
Medical specialty description
Clinical Chemistry
Device class
1
Regulation number
862.1330
Implant flag
N
Submission type ID
4
Harmonized identifiers (openFDA)
K number
K980055
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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.