One Step HCG Pregnancy Test midstream with CE Certificate 10mIU/ml Product Description
How to Use
Features & Benefits
Feature | Benefit |
One-step procedure | Easy to use, fewer procedural errors |
Results in 3 minutes | Fast time to results |
Two-color result | Easy to read and interpret |
High sensitivity | Ability to detect low hCG levels as early as 2-3 days before expected menses |
Self-contained test cassette | Clean, easy to use and dispose of |
Pictorial Procedure Card | Clear and simple illustrations to guide the hCG test procedure |
All components included in kit | Ready to use, no need for additional equipment |
External controls available | Facilitates internal laboratory quality control |
Room temperature storage | No refrigerator space needed. No need to wait for reagents to warm up. Rapid pregnancy urine tests Tests can be run immediately as needed |
Specification
Sample type | Urine |
Sample size | 3 drops |
Time to results | 3 minutes |
Kit storage conditions | Room temperature (2°C to 30°C/35.6°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 |
CLIA complexity | Waived |
FAQ 1.What is the shelf life of the QuickVue hCG Urine Test kit and hCG Control Set? How should they be stored? From date of manufacture:12 months, room temperature 2.What is the detection limit of the test? The Urine Test kit has a detection limit of 10 mIU/mL. 3.How soon after conception do your products detect pregnancy? In normal pregnancy, hCG can be detected as early as 6 days following conception with concentrations doubling every 32-48 hours. For some patients, an hCG level of 10 mIU/mL (clinically significant pregnancy level) can be detected as early as 2-3 days before expected menses. 4.Are there any diagnosis/conditions in which a patient may not have a normal pregnancy but produce a low-level positive test result? Ectopic pregnancy, undiagnosed (sub-clinical) abortion, spontaneous abortion, blighted ovum, patients with trophoblastic and non-trophoblastic disease may have elevated hCG levels. The possibility of hCG secreting hCG Urine Test neoplasms should be eliminated prior to the diagnosis of pregnancy. In addition, serum of postmenopausal women may also contain low levels of hCG. 5.Can I read the results after the read time has passed? Results are to be read at the 3 minute result read time. Results obtained when there are variations from the procedure cannot be guaranteed. Our Service > 24 hours online services > OEM,ODM and Customized is available > Quckly delivery time > Quickly and professional after sales service Payment & Shipment * OEM, OBM is available. * Packing Details: (BD)syringe needle or as requested * Shipping method: UPS, TNT, Fedex, DHL, EMS etc.
Company Introduction Hangzhou Singclean Medical Products Co., Ltd., established in March 2003 with registered capital of 80,000,000 RMB, is a national high and new technology enterprise integrating the R&D, production and sales of medical biomaterials. With well-qualified staff, thorough quality management system and first-class facilities, the company ensures the continuous production of medical devices and drug injection products of Class III that confirm to the laws and regulations of the State Food and Drug Administration (SFDA) and EU MDD. The company’s plant in Xiasha covers an area of 13,000 m² with the construction area of 17,000 m² and producing tract of 13,200 m² including cleanrooms of 2,300 m² in which cleanroom of Class C covers 2,000 m² and that of Class B covers 300 m² with over 60 m² of which follows into Class A. A new cleanroom up to GMP standard was set up in this plant, and the Pharmaceutical Production License was obtained in 2012. it will produce all kinds of medical equipment and medical 10 million sets, production value 2 billion, In addition, the plant has introduced more production facilities such as the Invoa filling machine from Germany, the sterilizer from GETINGE, the semiautomatic filling and sealing equipment from Pluemat, 5T / h purified water machine, 3T / h water for injection machine, and1T / h of pure steam generator.