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Universal Meditech Inc.

28 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
One Step Pregnancy Test REF 100-01 recall (Z-0042-2024)Universal Meditech Inc.2023-10-23
One Step Ovulation Test REF 200-01 recall (Z-0043-2024)Universal Meditech Inc.2023-10-23
HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10 recall (Z-0044-2024)Universal Meditech Inc.2023-10-23
HealthyWiser UriTest" UTI Test Strips REF 900-UTI recall (Z-0045-2024)Universal Meditech Inc.2023-10-23
HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test strips recall (Z-0046-2024)Universal Meditech Inc.2023-10-23
HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIP recall (Z-0047-2024)Universal Meditech Inc.2023-10-23
DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13 recall (Z-0048-2024)Universal Meditech Inc.2023-10-23
Am I Pregnant? One Step HCG Pregnancy Test REF 100-17 recall (Z-0049-2024)Universal Meditech Inc.2023-10-23
To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10 recall (Z-0050-2024)Universal Meditech Inc.2023-10-23
PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS recall (Z-0051-2024)Universal Meditech Inc.2023-10-23
PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips recall (Z-0052-2024)Universal Meditech Inc.2023-10-23
PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30 HCF recall (Z-0053-2024)Universal Meditech Inc.2023-10-23
PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips recall (Z-0054-2024)Universal Meditech Inc.2023-10-23
PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS recall (Z-0055-2024)Universal Meditech Inc.2023-10-23
PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE recall (Z-0056-2024)Universal Meditech Inc.2023-10-23
PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10 recall (Z-0057-2024)Universal Meditech Inc.2023-10-23
DiagnosUS One Step LH Ovulation Test Strip REF 200-07 recall (Z-0058-2024)Universal Meditech Inc.2023-10-23
DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10 recall (Z-0059-2024)Universal Meditech Inc.2023-10-23
DiagnosUS One Step FSH Menopausal Test (Strip) REF 210-07 recall (Z-0060-2024)Universal Meditech Inc.2023-10-23
Lem Fertility hCG Pregnancy Urine Test REF 100-12 recall (Z-0061-2024)Universal Meditech Inc.2023-10-23
Lem Fertility LH Ovulation Test (Strip) REF 200-07 recall (Z-0062-2024)Universal Meditech Inc.2023-10-23
DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12 recall (Z-0063-2024)Universal Meditech Inc.2023-10-23
DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13 recall (Z-0064-2024)Universal Meditech Inc.2023-10-23
DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27 recall (Z-0065-2024)Universal Meditech Inc.2023-10-23
DiagnosUS Pregnancy Test Midstream REF 100-17 recall (Z-0066-2024)Universal Meditech Inc.2023-10-23
DiagnosUS Ovulation Predictor Midstream REF 200-17 recall (Z-0067-2024)Universal Meditech Inc.2023-10-23
OMTMO One Step Ovulation (LH) Test Strips REF 200-07 recall (Z-0068-2024)Universal Meditech Inc.2023-10-23
Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal recall (Z-0929-2023)Universal Meditech Inc.2023-01-27

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Every clearance here is in the API, with alerts when new ones post.