MDI SM TEST

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K994029 ↗

FDA Product Code

LLL

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Elisa Test, Serology

  Class I

  FDA 510(k) K003794 Active Cleared 30 Mar 2001

• Mdi Sm/Rnp Test

  Class II

  FDA 510(k) K993635 Active Cleared 10 Jan 2000

• Mdi Ss-B Test Enzyme Immunoassay for the Detection of Autoantibodies to Ss-B in Human Serum

  Class II

  FDA 510(k) K993971 Active Cleared 11 Jan 2000

• Mdi Rf Test

  Class II

  FDA 510(k) K993843 Active Cleared 11 Jan 2000

• Mdi Gliadin G Test

  Class II

  FDA 510(k) K002359 Active Cleared 19 Oct 2000

• Mdi Gliadin a Test

  Class II

  FDA 510(k) K002358 Active Cleared 19 Oct 2000

See all devices from Micro Detect, Inc. →

• What is the MDI SM TEST device used for?

  The MDI SM TEST is an extractable antinuclear antibody, antigen and control device designed for manual procedures in immunology testing. It helps detect specific antibodies in patient samples for diagnostic purposes.

• How is the MDI SM TEST supplied?

  The device is supplied as a micro plate coated with specific antigens and controls, along with Wash Buffer, Sample Diluent, Conjugate, Substrate, and Stop Solution, providing all necessary components for testing.

• Is the MDI SM TEST single-use or reusable?

  The MDI SM TEST is intended for single-use in laboratory settings only. It should not be reused or repurposed for any other testing procedures to ensure accurate results and maintain safety standards.

• What is the regulatory status of the MDI SM TEST?

  The MDI SM TEST has received FDA 510(k) clearance with product code LLL and is classified as a Class 2 medical device. It is not indicated for MRI use and should be stored according to manufacturer instructions.