FDA 510K Cleared and CE certified one step Ovulation rapid test
OEM private logo, manual box, label ovulation strip/ LH ovulation 25miu strip
Specifications:
LH Ovulation Test Kit | |
Name | Rapid & High Accuracy LH Ovulation test strip |
Format | A. Strip |
| B. Cassette | |
| C. Midstream | |
Specimen | Urine |
Sensitivity (ng/ml) | 10-25 mIU/ml |
Size(mm) | A.Strip:2.5mm, 3.0mm, 3.5mm, 4.0mm,5.0mm, 6.0mm |
| B.Cassette: 4.0 mm | |
| C.Midstream:4.0mm, 6.0mm | |
Packing, OEM service are also accepted | A. Strip:1 test in a single pouch, 10000pcs in a carton |
| B. Cassette:1 test in a single pouch, 3000pcs in a carton | |
| C. Midstream: 1 test in a single pouch, 2400pcs in a carton | |
Accuracy | Over 99.5% |
Certificate | CE 0123,FDA 510K, ISO13485, CLIA-WAIVED |
Sample Lead time | Within 5 days |
Loading Port | Guangzhou/Shenzhen |
Our Main Products: Fertility and Ovulationtest, Pregnancy test, Infectious test, Drugs of Abuse test | |
HCG and LH Product Description:
Co-Innovation One Step HCG test strip is an in vitro diagnostic home use test device intended for the rapid determination of human chorionic gonadotropin (HCG) in urine to aid in the early detection of pregnancy.
Co-Innovation One Step LH Test Midstream/LH Strip/Cassette is a qualitative test used to predict when there is a LH surge, which is stated to be a reliable way by WHO.
Intended for over-the-counter (OTC) use
For in vitro diagnostic use only
Product Details:
How to use the HCG and LH Test:
ISO 13485, FDA 510K, CE 0123, CFS/FSC
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 FDA, 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.
3) We do observe the relevant for conduct & laws form government in environment, human rights and aspects like no children labor, no prisoner labor and so on.
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