Rally #188-1-2080
Quidel #00178
Reproductive Health Test Kit QuickVue+® One-Step hCG Combo hCG Pregnancy Test 30 Tests CLIA Waived Sample Dependent
TEST KIT, PREG HCG SERUM/URINECARDS QS (30/KT)
Features
- 10 mIU/mL sensitivity for serum and a 20 mIU/mL sensitivity for urine
- Can detect low levels as early as 2-3 days before expected menstruation
- Two color endpoint and +/- signs
- Test results within five minutes (serum); three minutes (urine)
- CLIA Waived- Urine
The QuickVue+ hCG Combo Test is a sensitive immunoassay that detects human chorionic gonadotropin (hCG) in serum or urine for the early detection of pregnancy. It uses a monoclonal antibody specific to the beta subunit of hCG in a single-step technology to accurately detect hCG.
Product Specifications
| Manufacturer # | 00178 |
| 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 | (30) Reaction Units, (30) Disposable Droppers, Package Insert, Procedure Card |
| Number of Tests | 30 Tests |
| Reading Type | Visual Read |
| Sample Type | Serum / Urine Sample |
| Specialty | Immunoassay |
| Test Format | Cassette Format |
| Test Kit Type | Rapid |
| Test Method | Lateral Flow Method |
| Test Name | hCG Pregnancy Test |
| Test Type | Fertility Test |
| Time to Results | 3 to 5 Minute Results |
| UNSPSC Code | 41116136 |
| Latex Free Indicator | Not Made with Natural Rubber Latex |
| Sample size | 4 drops |
| Kit storage conditions | Room temperature (15°C to 30°C/59°F to 86°F) |
| Internal controls | Positive and negative |
| External controls | Low positive, high positive and negative set available separately |
| Sensitivity | 10 mIU/mL (serum); 20 mIU/mL (urine) |
| Accuracy | > 99% |
| Shelf life | 21 months from date of manufacture |
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