Product Code: NAL
FDA class 2
21 CFR 862.1155
Test, Immunoassay, Biosensor, Hcg
Clinical Chemistry
The Immunoassay Biosensor for Human Chorionic Gonadotropin (hCG) is an in vitro diagnostic device using biosensor technology to measure hCG levels in patient specimens, supporting the diagnosis of pregnancy and monitoring of conditions such as gestational trophoblastic disease. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 862.1155 (Clinical Chemistry specialty). This device is eligible for third-party 510(k) review.
510(k)s
2
FEI Numbers
0
Registration Numbers
0
Unique Applicants
1
Years Active
2
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Basic Information
- Product Code
- NAL
- Device Class
- FDA class 2
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.