ENA III Test Kit (SCL-70 Autoantibody Reagents)
by Behring Diagnostics, Inc. 510(k)
Active
510(k) K871994
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK871994 | Date12 Aug 1987 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LLL
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5100
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
This device is an Extractable Antinuclear Antibody, Antigen And Control test system used to measure autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents. It is designed for immunochemical techniques to detect antibodies targeting nuclear molecules such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins.
The ENA III Test Kit (SCL-70 Autoantibody Reagents) is supplied as reagents for in vitro diagnostic use. It is a Class II device with product code LLL, cleared under FDA 510(k) K871994, and falls under regulation number 866.5100. The device is intended for use in immunology laboratories and is not described as sterile, single-use, reusable, or MRI-safe in the provided data.
Other devices from Behring Diagnostics, Inc.
Questions
AI-generated answers, 24 Sep 2026
What is the ENA III Test Kit (SCL-70 Autoantibody Reagents) used for?
It is used to measure autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents, specifically targeting antibodies against nuclear molecules such as RNA, DNA, or nuclear proteins via immunochemical techniques.
How is the ENA III Test Kit supplied and what is its intended use setting?
The device is supplied as reagents for in vitro diagnostic use and is intended for use in immunology laboratories, as stated in the provided data.
Is the ENA III Test Kit described as sterile, single-use, or reusable in the device data?
The provided data does not describe the device as sterile, single-use, reusable, or MRI-safe, so no such claims can be made based on the information given.