The One Step Ovulation Test is a rapid chromatographic immunoassay for the qualitative detection of luteinizing hormone (LH) in urine to aid in the detection of ovulation.
These SKUs are available for sale in the US.
| Product Description | Specimen | Catalog No. | Format | Cut-off Value | Kit Size | Regulatory Clearance |
|---|---|---|---|---|---|---|
| LH Ovulation Test | Urine | GALH-101a√ | Strip | 25 mIU/mL | 100 Tests/Kit | 510(k) OTC, CLIA WAIVED, CE-IVDD |
| LH Ovulation Test | Urine | GALH-101b√ | Strip | 40 mIU/mL | 100 Tests/Kit | CE-IVDD |
| LH Ovulation Test | Urine | GALH-101d | Strip | 30 mIU/mL | 100 Tests/Kit | CE-IVDD |
| LH Ovulation Test | Urine | GALH-101i | Strip | 40 mIU/mL | Pro: 100 Tests/Kit OTC:1/2/5/10/15/25 Test(s)/Kit | / |
| LH Ovulation Test | Urine | GALH-101g | Strip | 25 mIU/mL | Pro: 100 Tests/Kit OTC:1/2/5/10/15/25 Test(s)/Kit | / |
| LH Ovulation Test | Urine | GALH-102a√ | Cassette | 25 mIU/mL | 25 Tests/Kit | 510(k) OTC, CLIA WAIVED, CE-IVDD |
| LH Ovulation Test | Urine | GALH-102b√ | Cassette | 40 mIU/mL | 25 Tests/Kit | CE-IVDD |
| LH Ovulation Test | Urine | GALH-102i | Cassette | 40 mIU/mL | Pro: 25 Tests/Kit OTC:1/2/5/10/15/25 Test(s)/Kit | CE-IVDD |
| LH Ovulation Test | Urine | GALH-102g | Cassette | 25 mIU/mL | Pro: 25 Tests/Kit OTC:1/2/5/10/15/25 Test(s)/Kit | / |
| LH Ovulation Test | Urine | GALH-103a√ | Midstream | 25 mIU/mL | 1/5 Test(s)/Kit | / |
| LH Ovulation Test | Urine | GALH-103b√ | Midstream | 40 mIU/mL | 1/5 Test(s)/Kit | CE-IVDD |
| LH Ovulation Test | Urine | GALH-103d | Midstream | 30 mIU/mL | 1/5 Test(s)/Kit | CE-IVDD |
| LH Ovulation Test | Urine | GALH-103i | Midstream | 40 mIU/mL | 1/2/5/10/15/25 Test(s)/Kit | CE-IVDD |
| LH Ovulation Test | Urine | GALH-103g | Midstream | 25 mIU/mL | 1/2/5/10/15/25 Test(s)/Kit | CE-IVDR |
*This claim has not been reviewed by the FDA.
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