Product Description
One Step HCG Test kits is an in vitro diagnostic home use test device intended for the rapid determination of human chorionic (hCG) in urine to aid in the early detection of pregnancy. You can easily carry out yourself. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.
Our Advantage:
1. low MOQ
2.Quick reply
3.short lead time
4.OEM/ODM service avaliable
5. high sensitive accuracy up to 99.8%
6. rapid test kits are produced with imported materials
7. Factory direct sales
Product type
Strips type:
Midstream type:
Cassette type:
Product Parameters
Characteristic
| Product Names |
HCG TEST misdtreams/strip/cassette |
| Width Size |
2.5/3.0/3.5/4.0/5.0/6.0 mm |
| Sensitivity |
10, 20, 25mIu/ml |
| Specimen |
Urine |
| Accuracy |
≥ 99% |
| Read time |
3-5 Minutes |
| Shelf Validity |
24-36 Months |
| Storage |
4ºC to 30ºC |
| Certificates |
ISO13485, CE, FDA 510K, FSC, MHRA |
| Application |
Home care, Hospital, Clinic, Professional test |
| Package |
10000pcs ( 1 carton )
Dimension of carton: 0.096CBM
Gross weight: 21Kgs |
| Customization Service |
OEM-Manual, Private Labeling, Sealed Pouches, Inner Box |
Product Key Features:
* Easy to use
* Easy to read
* Able to test any time of day
* Detect pregnancy as early as 1 day after the missed period
* Room temperature storage
How to do the Test ?
For cassette
1, Remove a Testing Device from the foil pouch by tearing at the notch and place it on a level surface.
2,Holding a sample dropper vertically, add 3 drops of the urine specimen to the sample well (with an arrow marked).
3, Read the result in five minutes. Positive results may sometimes appear as early as one minute but you should wait the full 5 minutes before determining a negative result.
Do not read results after more than 5 minutes.
For Strip:
1.The test strip and urine have to be at room temperature 59-86ºF (15-30°C) for testing.
2.Remove the test strip from the sealed pouch.
3.Immerse the strip into the urine with the arrow pointing towards the urine. Take the strip out after 5 seconds and lay the strip flat on a clean, dry, non-absorbent surface (such as the mouth of the urine container).
IMPORTANT: Do not allow the urine level to exceed the MAX (marker line), otherwise the test will not perform correctly.
4.Read results in five minutes.Positive results may sometimes appear as early as one minute but you should wait the full 5 minutes before determining a negative result. Do not read results after more than 5 minutes.
For Midstream:
1. To begin testing, open the sealed pouch by tearing along the notch. Remove test device--midstream from the pouch. Hold the round end of cover with one hand. Use the other hand to pull out the midstream cap and expose the absorbent.
2. Point the absorbent pad downward; place the absorbent pad in urine stream for at least 10 seconds to be thoroughly wet. Do not urinate passed the arrow mark.
Otherwise, you can collect your urine into a clean cup and dip half of the absorbent pad into the urine for at least 5 seconds.
3. Re-cap the device and wait for color bands to appear. Read the result in five minutes. Positive results may sometimes appear as early as one minute but you should wait the full 5 minutes before determining a negative result.Do not read results after more than 5 minutes.
Company Profile
Co-Innovation is an innovative and creative enterprise in R&D, manufacturing and marketing of rapid diagnostics tests.
In 2012, Co-innovation was established in Guangzhou, China. Specialized in lateral flow immunoassay technology, we provide diagnostics tests to global market with pregnancy tests, ovulation predictor, drug of abuse tests.
Our products are being sold to many countries, including United States, Germany, Netherlands, England, Chile, Ecuador, Malaysia, Singapore, India, Australia etc.
Our products have been widely recognized and enormously supported, we aim to produce high cost-effective products, and create the greatest value for customers.
Installation Instructions
Packing details:
Certifications:
ISO 13485, CE 0123, FDA, CFS, MHRA
Enterprise Dynamics
Exhibition in 2023 Beijing
Exhibition in 2023 AACC (America)
FAQ
1: You are manufacturer or a trading company?
CIBIO is a professional manufacturer specializing in manufacturing Prenancy and Fertility Test, Drug of Abuse(Single Test and Multi Test). We enjoy great reputation among our customers not only for competitive price, qualified product but also for excellent service.
2:How to get samples?
It is our great honor to offer you samples for free, but new clients are expected to pay the courier cost.
You can arrange a remote pick-up service upon Fedex,UPS,DHL,etc.to have samples collected; or your DHL collection account is ok too.
3: Do you offer OEM or ODM Service?
Yes, we can do OEM or even ODM. All of our products can be customized
4:How does your factory do regarding quality control?
Quality is Life! So we always focus on quality controlling during the whole process.
1) We have 510k, CE, ISO13485 certification, so far all the production process, we have standard rules;
2) We have QC team, we have third times QC before shipping out cargo.
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