PHF · Class II · 21 CFR 866.5670

FDA Product Code PHF: Zinc Transporter 8 Auto-antibody

The Zinc Transporter 8 Autoantibody (znt8ab) Elisa Assay Is For The Semi-quantitative Determination Of Autoantibodies To Zinc Transporter 8 (znt8) In Human Serum. The Zinc Transporter 8 Autoantibody (znt8ab) Elisa Assay May Be Useful As An Aid In The Diagnosis Of Type 1 Diabetes Mellitus (autoimmune Mediated Diabetes). The Znt8ab Assay Is Not To Be Used Alone And Is To Be Used In Conjunction With Other Clinical And Laboratory Findings.

1
Total
0
Cleared
65d
Avg days
2014
Since

FDA 510(k) Cleared Zinc Transporter 8 Auto-antibody Devices (Product Code PHF)

1 devices
1–1 of 1
No devices found for this product code.

About Product Code PHF - Regulatory Context