Enzyme Immunoassay, Inhibin-A
The Enzyme Immunoassay, Inhibin-A (product code NDR) is an in vitro diagnostic test used to quantitatively measure inhibin-A levels in serum or plasma, with applications in prenatal screening for Down syndrome and monitoring of ovarian function. It is classified as an FDA Class 1 device within the Clinical Chemistry specialty, subject to general controls and exempt from 510(k) premarket notification. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- NDR
- Device Class
- FDA class 1
- Regulation Number
- 862.1260
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K002128 | ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 | Dec 05, 2000 | Substantially Equivalent | Diagnostic Systems Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.