

QUICKVUE® ONE-STEP HCG TEST
(30 Tests) This One Step hCG Combo test for the qualitative detection of hCG in serum or urine for the early detection of pregnancy, has 25 mIU/mL sensitivity. FDA Cleared & CLIA waived for urine, Moderate Complex for Serum. FDA 510K#: K020801 - QuickVue One-Step hCG Urine
The QuickVue One-Step hCG Urine test, 30 tests, is a sensitive immunoassay for the qualitative
detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy.
Features & Benefits
Feature
Benefit
Two-Color Endpoint with white background:
Easy-to-interpret results.
25 mIU/mL Sensitivity:
Ability to detect low hCG levels as early as 2-3 days before expected menses.
Sample size - 3 drops:
No large sample required.
Results in 3 minutes:
Fast time to results.
Easy to Use:
No special training needed.
Room Temp Storage:
Valuable refrigerator space available for other items.
Shelf Life:
18 months*
Distribution:
Available from local distributor - often with no additional shipping charges.
Manufactured by Quidel:
Focus is on rapid diagnostic products.
Price:
Quality product - competitively priced.
Technical Support:
Professional staff available for assistance.
* From date of manufacture
Product Specification
Method:
Lateral flow test - no reagents
Accuracy:
> 99%
Time to Result:
Read at 3 minutes
Storage:
18 months at room temperature*
External Controls:
Positive and Negative Control Set available (Cat. #00272)
Catalog Numbers:
20109 (25 Tests)
Kit Contents:
Test cassettes
Pipettes
Package Insert
Procedure Card
Sample Size:
3 drops urine
* From date of manufacture
-Catalog #: QUI20109
-Quantity: 30 Tests
-FDA 510k , CLIA Waived
-Reimbursement: CPT*:
81025QW* ($9.24) - Urine, National Limit
84703QW ($10.49) - Serum
-This product is for professional use only and it is always healthcare provider responsibility to establish reimbursements.