our company can absolutely do custom packaging on these midstream tests—vial sizes, labeling, even the box design—so if you're targeting a specific market or chain, just tell us the specs and we'll adjust whole run around it.
Basically it's a colloidal gold immunoassay that picks up LH in urine at 25mIU/ml, and the whole thing is done in under a minute with a reading window of about ten minutes or so. Most buyers go with the 5.5mm width for home kits, but we've got 3.0mm and 6.0mm options too if you're testing different batch formats.

It works by that double antibody sandwich method—the test line has anti-α hLH pre-coated, and the control line uses goat anti-mouse IgG—so what it does is give you a clear yes/no on the surge. The sensitivity is more than enough for home use, but don't expect it to work for serum or anything like that; it's strictly for urine.
You're looking at a shelf life of two years form manufacture, and we typically stock the 1-test and 5-test boxes in bulk, but the 7-test and 25-test formats are availble with about a 20-day lead time. CE and ISO13485 come with every batch, and we'll send the COA on request—it's something most suppilers don't offer upfront.

We've been making these for years, so one thing I'll mention is the plastic casing—ABS material—which holds up fine during shiping, but if you're planning to store them in high heat for long periods, the stability can dip a bit. It's not a dealbreaker, but worth knowing if your warehose runs hot.
Anyway, the 99.99% accuracy stat is real, but that's under controlled conditions—real-world use with variable timing and hydration levels might drop it slightly, though still better than reagent grade strips for this application.
The shelf life is 2 years from the date of manufacture. Store in a cool, dry place between 2-30°C, and make sure the foil pouch is sealed until you're ready to use it.
It means the test can detect LH levels as low as 25 milli-International Units per milliliter of urine, which is the standard threshold for predicting the LH surge that triggers ovulation. This level gives you a reliable heads-up on your fertile window.
Yes, we offer full OEM/ODM customization. You can choose your own logo, box design, and even the test width from options like 3.0mm, 5.0mm, 5.5mm, or 6.0mm. Just let us know your requirements.
We hold both CE and ISO13485 certifications, which means our manufacturing process meets strict quality standards. The 99.99% accuracy is based on clinical testing against a reference method.
Our MOQ typically starts at 10,000 units for standard packaging, but we can discuss lower quantities for first-time orders or custom designs. Just reach out to our sales team for the exact numbers.