ELISA-DOXA SM
by Advanced Biological Products, Inc.
510(k) K924947
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK924947 | Date19 May 1993 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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, 1 Oct 2026
The ELISA-DOXA SM is an Extractable Antinuclear Antibody, Antigen And Control device used in immunology testing. It is designed for laboratory use to detect specific antibodies and antigens in patient samples.
This device is supplied as a single-use product and requires appropriate storage conditions. It has FDA 510(k) clearance with product code LLL and is classified as Class II medical device. The device is not indicated for MRI use and should be handled according to standard laboratory protocols.
Other devices from Advanced Biological Products, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the ELISA-DOXA SM device used for?
The ELISA-DOXA SM is an Extractable Antinuclear Antibody, Antigen And Control device designed for laboratory use to detect specific antibodies and antigens in patient samples for immunology testing purposes.
Is the ELISA-DOXA SM a single-use device?
Yes, the ELISA-DOXA SM is supplied as a single-use product and should be handled according to standard laboratory protocols to ensure accurate test results and patient safety.
What is the regulatory classification of the ELISA-DOXA SM?
The ELISA-DOXA SM has FDA 510(k) clearance with product code LLL and is classified as a Class II medical device, indicating it requires special controls for safety and effectiveness.
How should the ELISA-DOXA SM be stored?
The ELISA-DOXA SM requires appropriate storage conditions as specified by the manufacturer to maintain its integrity and performance characteristics for laboratory testing.