Helix Diagnostics, Inc.
ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST
SKU K000489UPC LLL
In Stock
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IIFDA 510(k) Cleared (K000489)
1
Free shipping on orders over $99 · 30-day returns
Helix Diagnostics, Inc.
Free shipping on orders over $99 · 30-day returns
ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST is an FDA 510(k)-cleared medical device (K000489) manufactured by Helix Diagnostics, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 4, 2000. Regulation: 8.
