Test, Carbohydrate Deficient Transferrin
The Carbohydrate Deficient Transferrin (CDT) Test is a clinical chemistry in vitro diagnostic device used to measure carbohydrate-deficient transferrin in serum, which serves as a biomarker for chronic alcohol misuse and is used in clinical and occupational medicine settings. Classified as FDA Class 1, it is subject to general controls under regulation 862.1360 (Clinical Chemistry specialty). This low-risk device requires only general controls.
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Basic Information
- Product Code
- NAO
- Device Class
- FDA class 1
- Regulation Number
- 862.1360
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K060677 | N LATEX CDT | Aug 25, 2006 | Substantially Equivalent | Dade Behring, Inc. |
| K001943 | CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY | Aug 23, 2000 | Substantially Equivalent | Sangui Biotech, Inc. |
| K992502 | AXIS %CDT TURBIDIMETRIC IMMUNOASSAY | Dec 21, 1999 | Substantially Equivalent | Axis |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.