Medix Biotech Strep a Antigen Detection Test (Modification)

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K952873 ↗

FDA Product Code

GTZ

Device Class

Class I

Regulation

21 CFR Part 866.3740

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Medix Biotech Bestest(Tm) Hcg-Urine, Cat# B1H0100

  Class II

  FDA 510(k) K924259 Active Cleared 25 Nov 1992

• Tsh Enzyme Immunoassay Test Kit No. Mb-1093

  Class II

  FDA 510(k) K874061 Active Cleared 3 Nov 1987

• Hcg Enzyme Immunoassay Test Kit Catalog #mb-1013

  Class II

  FDA 510(k) K873872 Active Cleared 28 Oct 1987

• Medix Biotech Hghenzyme Immunoassay Test Kit

  Class I

  FDA 510(k) K920299 Active Cleared 4 Mar 1992

• Medix Biotech Prolactin Enzyme Immuno. Test Kit

  Class I

  FDA 510(k) K873355 Active Cleared 9 Oct 1987

• Medix Visual Urine Hcg (7/7) Test

  Class II

  FDA 510(k) K850949 Active Cleared 12 Apr 1985

See all devices from Medix Biotech, Inc. →