Helix Diagnostics, Inc.
FDA 510(k) medical device clearances.
Top product codes for Helix Diagnostics, Inc.
Recent clearances by Helix Diagnostics, Inc.
- K001900 — ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST
- K000489 — ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST
- K980337 — DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM
- K960091 — ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT
- K954700 — ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT
- K954723 — ENZYME IMMUNOASSAY ANA SCREENING TEST KIT
- K952253 — ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT
- K951850 — ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT
- K951798 — ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT
- K940510 — ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT
- K940588 — ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT
- K932850 — ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN
- K932419 — ANTI-SS-B/LA ANTIBODY TEST
- K931495 — ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT
- K913041 — ANTI-DSDNA ANTIBODY TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.