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Oct . 06, 2025 07:45 Back to list

China urine pregnancy test strip: 99% accuracy, OEM/ODM?

Home diagnostics is booming, and the humble collection cup has quietly become the unsung hero of the china urine pregnancy test strip workflow. In clinics and, frankly, in bathrooms at 6 a.m., a reliable container111 means fewer retests and cleaner results. I’ve toured plants in Hebei and Guangdong—what surprised me wasn’t just the speed of production, but how the right cup design noticeably reduces invalid tests.

China urine pregnancy test strip: 99% accuracy, OEM/ODM?

Industry snapshot: from pharmacy shelves to telehealth kits

Retail pregnancy tests keep growing alongside telehealth starter kits. Many buyers now ask for cups pre-matched to strip depth and minimum volume—because, to be honest, pouring from a mug isn’t a great lab protocol. Chinese OEMs respond with nimble runs, custom lids, and multi-pack film wrapping that plays nicely with e-commerce fulfillment.

China urine pregnancy test strip: 99% accuracy, OEM/ODM?

Product in focus: Urine Cups Plastic Disposable Cups (Hebei)

Made at No.136, Shiji West Road, Gaobeidian City, 074000, Hebei Province, P.R. China, these cups are designed around the depth and volume needs of china urine pregnancy test strip formats—think 30–60 mL targets and enough headroom to avoid splash or strip over-immersion.

Spec Details (≈ = typical)
Capacity 30 mL, 40 mL, 50 mL, 60 mL
Material High-quality PP/PE (medical-grade; low hCG adsorption in real-world use)
Sterility Sterile or non-sterile; EO or gamma options
Packaging Custom: 3 pc/pack, 20 pc/pack, heat-shrink film
Shelf life ≈2–5 years (storage: 2–30°C, dry, away from UV)
Compliance ISO 13485 QMS, ISO 14971 risk management; sterilization per ISO 11137
Use-fit Optimized for china urine pregnancy test strip dip-depth and 10–15s immersion

Depending on selected sterile option.

China urine pregnancy test strip: 99% accuracy, OEM/ODM?

How it’s made (quick process flow)

Materials: medical-grade PP/PE pellets → drying → injection molding → deburring/visual inspection → (optional) EO/gamma sterilization → packaging (multi-pack or single-wrap) → leak & drop tests → lot release under ISO 13485.

Tests and standards: leakage (≥95 kPa short-duration), lid torque, scale tolerance, biocompatibility screening per ISO 10993 extracts, sterility validation (if sterile) per ISO 11137. For the strip workflow itself, qualitative performance typically aligns with CLSI EP12 guidance; many customers say that cups with anti-drip lips reduce user error more than they expected.

Vendor (China) Certs MOQ Customization Lead time Notes
PrisesBio (Hebei) ISO 13485; sterility validated ≈5,000–10,000 Logo, color, pack counts, lids 2–4 weeks Strong OEM for china urine pregnancy test strip kits
Vendor B (Zhejiang) ISO 9001/13485 ≈20,000 Basic color/pack 3–6 weeks Competitive FOB pricing
Vendor C (Guangdong) ISO 13485, CE MDR (IVD accessories) ≈10,000 Advanced: embossed scales, barcodes 4–5 weeks Focus on export documentation
China urine pregnancy test strip: 99% accuracy, OEM/ODM?

Real-world use, test data, and feedback

  • Typical hCG sensitivity for strips: ≈25 mIU/mL; read window: 3–5 minutes; urine volume: 1–3 drops on cassette or 5–10 mm dip on strips.
  • Clinics report fewer contaminated samples when using sterile cups for early pregnancy confirmations; one Hebei chain cited ≈18% fewer repeats after switching to sealed 3-packs (internal QA, it seems).
  • Home users like easy-grip rims; surprisingly, clear volume marks reduce over-dipping errors with china urine pregnancy test strip formats.
China urine pregnancy test strip: 99% accuracy, OEM/ODM?

Where these cups fit

- Home self-testing kits and telehealth bundles. - OB-GYN clinics, community health, pharmacy walk-ins. - Manufacturing lines packaging china urine pregnancy test strip kits with matched accessories.

Buying tips and customization

Ask for PP resin data sheets, sterility certificates (if applicable), lot traceability, and drop/leak test reports. For branding, custom lid colors and shrink-wrapped 3/20-packs are common. If you export, verify ISO 13485 and risk files (ISO 14971); for sterile SKUs, request ISO 11137 validation and bioburden controls.

Authoritative citations

  1. ISO 13485: Medical devices — Quality management systems. https://www.iso.org/standard/59752.html
  2. ISO 11137: Sterilization of health care products — Radiation. https://www.iso.org/standard/60887.html
  3. CLSI EP12-A2: User Protocol for Evaluation of Qualitative Test Performance. https://clsi.org/
  4. ISO 10993 series: Biological evaluation of medical devices. https://www.iso.org/committee/54960.html
  5. U.S. FDA IVD guidance for hCG test systems (510(k) submissions). https://www.fda.gov/
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