This page includes the latest FDA filings for Helix Diagnostics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Device Company | Device | Date |
|---|---|---|
HELIX DIAGNOSTICS, INC. | ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST | 2000-09-11 |
HELIX DIAGNOSTICS, INC. | ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST | 2000-04-05 |
HELIX DIAGNOSTICS, INC. | DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM | 1998-05-12 |
HELIX DIAGNOSTICS, INC. | ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT | 1996-03-20 |
HELIX DIAGNOSTICS, INC. | ENZYME IMMUNOASSAY ANA SCREENING TEST KIT | 1995-12-15 |
HELIX DIAGNOSTICS, INC. | ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT | 1995-12-15 |
HELIX DIAGNOSTICS, INC. | ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT | 1995-08-24 |
HELIX DIAGNOSTICS, INC. | ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT | 1995-07-18 |
HELIX DIAGNOSTICS, INC. | ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT | 1995-07-17 |
HELIX DIAGNOSTICS, INC. | ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT | 1994-04-20 |
HELIX DIAGNOSTICS, INC. | ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT | 1994-04-20 |
HELIX DIAGNOSTICS, INC. | ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN | 1993-09-24 |
HELIX DIAGNOSTICS, INC. | ANTI-SS-B/LA ANTIBODY TEST | 1993-08-05 |
HELIX DIAGNOSTICS, INC. | ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT | 1993-07-16 |
HELIX DIAGNOSTICS, INC. | ANTI-DSDNA ANTIBODY TEST | 1991-11-05 |