Anti-Dna Antibody, Antigen And Control
The Anti-DNA Antibody, Antigen and Control combination device is an in vitro diagnostic system used to detect antibodies to double-stranded DNA (dsDNA) in patient serum, including the antigen and control components necessary for assay performance, primarily used in the evaluation of systemic lupus erythematosus (SLE). It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification. The product code is LSW, regulated under 21 CFR 866.5100, within the Immunology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
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Basic Information
- Product Code
- LSW
- Device Class
- FDA class 2
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K172348 | AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10 | Feb 16, 2018 | Substantially Equivalent | Aesku.Diagnostics GmbH & Co. KG |
| K152013 | QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls | Apr 11, 2016 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K081251 | MODIFICATION TO AESKULISA DS DNA G | May 13, 2008 | Substantially Equivalent | Aesku Diagnostics |
| K072393 | ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01 | Dec 07, 2007 | Substantially Equivalent | Phadia US, Inc. |
| K060380 | FIDIS DSDNA | May 02, 2006 | Substantially Equivalent | Biomedical Diagnostics (Bmd) SA |
| K041628 | AESKULISA DS DNA G | Oct 14, 2004 | Substantially Equivalent | Aesku Diagnostics |
| K921658 | ANTI-DSDNA ANTIBODY TEST | Mar 22, 1993 | Substantially Equivalent | Immco Diagnostics, Inc. |
| K872085 | THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS | Sep 01, 1987 | Substantially Equivalent | Immunodiagnostics, Ltd. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.