Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Universal Meditech with 28 device recalls. The most recent is a device recall dated May 22, 2023: DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| May 22, 2023 | DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10Class II · Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Ant | Device recalls |
| May 22, 2023 | PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTSClass II · Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Ant | Device recalls |
| May 22, 2023 | PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10Class II · Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Ant | Device recalls |
| May 22, 2023 | DiagnosUS Pregnancy Test Midstream REF 100-17Class II · Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Ant | Device recalls |
| May 22, 2023 | PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREEClass II · Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Ant | Device recalls |
| May 22, 2023 | Lem Fertility hCG Pregnancy Urine Test REF 100-12Class II · Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Ant | Device recalls |
| May 22, 2023 | DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13Class II · Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Ant | Device recalls |
| May 22, 2023 | OMTMO One Step Ovulation (LH) Test Strips REF 200-07Class II · Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Ant | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
