Is-Dsdna Test System
510(k) K974694
Is-Dsdna Test System is a Class II device made by Diamedix Corp., cleared under FDA 510(k) K974694 on 3 Mar 1998, active as of 10 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK974694 | Date3 Mar 1998 | StatusActive |
Official records
- FDA 510(k) database K974694
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LRM
- Device class
- Class II
- Regulation
- 21 CFR Part 866.5100
- Advisory committee
- Immunology
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code LRM (Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control).
- ENCORE DS-DNA by CLARK LABORATORIES, INC.
- Liquichek Anti-DsDNA Control, Model 213 by Bio-Rad
- Enzyme Immunoassay Anti-ssDNA Antibody Test by Helix Diagnostics, Inc.
- AUTOSTATTMII ANTI-DSDNA by Cogent Diagnotics, Ltd.
- HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY by HYCOR BIOMEDICAL LLC
- 3M ANTI-DSDNA FAST TEST by 3M Diagnostic Systems, Inc.
- Anti-dsDNA-NcX ELISA (IgG) EA 1572-9601 G by EUROIMMUN Medizinische Labordiagnostika AG
- ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS) by Amersham Corp.
- VARELISA DSDNA ANTIBODIES (FARR VERSION) by Elias U.S.A., Inc.
- ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT by Helix Diagnostics, Inc.