Helix Diagnostics, Inc.
Helix Diagnostics, Inc. holds FDA 510(k) medical device clearances, first cleared 1991, most recent 2000.
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.