Home - Women’s Health - DAVID® | Luteinizing Hormone (LH) Test Strip | Ovulation Prediction | DengYueRX
Description
Indication & Scope
DAVID® (Luteinizing Hormone (LH) Test Strip) is intended for the in vitro qualitative detection of luteinizing hormone in female urine to identify the LH surge and assist in predicting the approximate timing of ovulation. The test may be used to help identify the fertile window for conception planning and as a reference for fertility awareness-based contraception. It is intended only as an ovulation screening aid and is not designed for disease diagnosis.
- Mechanism: The test uses a colloidal gold immunochromatographic assay based on a double-antibody sandwich principle. Anti-LH monoclonal antibodies recognize LH in the urine sample, producing a visible test line when the LH concentration reaches the detection threshold.
- Device class: Class II medical device; in vitro diagnostic device.
- Clinical use: Home or point-of-care qualitative screening of urinary LH to identify an LH surge and assist with ovulation prediction.
| Generic Name | Luteinizing Hormone (LH) Test Strip |
| Brand Name | DAVID® |
| Ingredient | Anti-α-LH Monoclonal Antibody, Anti-β-LH Monoclonal Antibody, Monoclonal IgG Antibody, Colloidal Gold, Buffer Salts, Nitrocellulose Membrane, Absorbent Paper, Plastic Substrate |
| Dosage Form | Test Strip |
| Package | 1 test/foil pouch, 10 pouches/box |
| Conditions Treated | Qualitative detection of urinary LH for ovulation prediction |
| Taboos | Results may be unreliable in certain endocrine or ovarian disorders and during use of hCG-containing ovulation-induction medicines |
| Place of origin | China |
| Prescription type | Class II Medical Device |
| Storage Conditions | Store at 2–35°C in a dry place protected from light. Do not freeze. |
| Manufacturer | Guangdong Ekanas Biomedical‑Technology Co., Ltd |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval Number | Guangdong Medical Device Registration No.20162400112 |
| Approval Date | October 8, 2025 |
| Shelf Life | 30 months |
How to use ?
Recommended Dose: Collect a urine sample and test according to the instructions provided with the kit.
Time: Test preferably between 10:00 a.m. and 8:00 p.m., avoiding the first morning urine. Reduce excessive fluid intake for approximately 2 hours before testing to avoid dilution of the urine sample.
Instructions for use: Negative: Only the control (C) line appears, or the test (T) line is lighter than the C line, indicating that an LH surge has not been detected. Continue daily testing as appropriate. Positive: The T line is equal to or darker than the C line, indicating an LH surge and suggesting that ovulation may occur approximately within the following 24–48 hours. Invalid: The C line does not appear. The test should be considered invalid and repeated with a new test strip.
Interaction: hCG-containing fertility medicines may interfere with the test result. Certain ovarian or endocrine disorders and irregular menstrual cycles may also affect the interpretation of urinary LH results.
Side effects: The test is an external in vitro diagnostic device and is not expected to cause pharmacological adverse effects when used as directed.
Important Notice
This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indication, and regional regulatory requirements.
Packaging & Shipping
Packaging
Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.
Shipping Methods
Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.
Export Support
Certificate of Analysis
GMP Certificate
Commercial Invoice
Packing List & CPP
Cold Chain Logistics
Customs Documentation
Scientific and regulatory sources
FAQ
What is DAVID® (Luteinizing Hormone (LH) Test Strip) LH Test Strip?
DAVID® (Luteinizing Hormone (LH) Test Strip) is a Class II in vitro diagnostic device that qualitatively detects LH in female urine and helps identify the LH surge associated with impending ovulation.
What does a positive result mean?
A positive result indicates that urinary LH has reached the test’s detection threshold, suggesting an LH surge. Ovulation may occur approximately within the following 24–48 hours, although the test cannot determine the exact time of ovulation.
Can the DAVID® (Luteinizing Hormone (LH) Test Strip) be used for contraception?
DAVID® (Luteinizing Hormone (LH) Test Strip) may be used as a reference for fertility awareness, but it should not be relied upon as a standalone contraceptive method because LH testing cannot precisely determine the fertile period or guarantee that pregnancy will be prevented.
What can cause an inaccurate or difficult-to-interpret result?
Urine dilution, irregular menstrual cycles, hormonal fluctuations, certain ovarian or endocrine conditions, and hCG-containing fertility medicines may affect test results. Users with persistent fertility concerns should seek appropriate medical evaluation.
DAVID® | Luteinizing Hormone (LH) Test Strip | Ovulation Prediction | DengYueRX
Product Name: Luteinizing Hormone (LH) Test Strip
Indications: Qualitative detection of urinary LH for ovulation prediction
Dosage Form: Test Strip
Specification: 1 test/Foil Pouch
$2.14 Original price was: $2.14.$1.82Current price is: $1.82.
Availability: 5 in stock
Low MOQ
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DAVID® | Luteinizing Hormone (LH) Test Strip | Ovulation Prediction | DengYueRX
$2.14 Original price was: $2.14.$1.82Current price is: $1.82.
Availability: 5 in stock