Rally #188-1-2110
Quidel #20110
Reproductive Health Test Kit QuickVue® One-Step hCG Combo hCG Pregnancy Test 50 Tests CLIA Waived Sample Dependent
TEST KIT, PREG HCG SERUM/URINE QUICKVUE 1STP (50/KT)
Features
QUIDEL QUICKVUE® ONE-STEP HCG COMBO TEST is a sensitive immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum and urine for the early detection of pregnancy. Detects 25 mIU/mL hCG in serum and urine. Results in 5 minutes (serum) / 3 minutes (urine). Greater than 99% sensitivity, specificity and accuracy. Room temperature storage. Simple one-step procedure uses only 3 drops of sample. CLIA waived for urine.
Product Specifications
| Manufacturer # | 20110 |
| Brand | QuickVue® One-Step hCG Combo |
| Manufacturer | Quidel |
| Country of Origin | United States |
| Application | Reproductive Health Test Kit |
| CLIA Classification | CLIA Waived for Urine / CLIA Moderate Complexity for Serum |
| CLIA Classified | CLIA Waived Sample Dependent |
| Contents 1 | (50) Test Cassettes, (50) Pipettes, Package Insert, Procedure Card |
| Number of Tests | 50 Tests |
| Reading Type | Visual Read |
| Sample Type | Serum / Urine Sample |
| Sample size | 3 drops |
| Time to results | Serum – 5 minutes; Urine – 3 minutes |
| Specialty | Immunoassay |
| Test Format | Cassette Format |
| Test Kit Type | Rapid |
| Test Method | Lateral Flow Method |
| Test Name | hCG Pregnancy Test |
| Test Type | Fertility Test |
| UNSPSC Code | 41116205 |
| Latex Free Indicator | Not Made with Natural Rubber Latex |
| Kit Storage Conditions | Room temperature (15˚C to 30˚C/59˚F to 86˚F) |
| Internal Controls | Included |
| External Controls | Available separately |
| Sensitivity | 25 mIU/mL |
| Accuracy | > 99% |
| Shelf life | 18 months from date of manufacture |
| Weight (Pounds) | 1.10 |
Main Documentation
- CLSI - QuickVue hCG Combo Test
- Package Insert - QuickVue hCG Combo Test
- Procedure Card - QuickVue hCG Combo Test
- SDS - QuickVue hCG Combo Test
- SDS - QuickVue hCG Combo Test - Serum
- SDS - QuickVue hCG Combo Test - Urine
- Sales Sheet - QuickVue hCG Combo Test
- Technical Bulletin - Heterophilic Antibody Blockers
- Technical Bulletin - Hook Effect
