Urine Test Strips Manufacturer — 12 Parameters Bulk Wholesale for IVD Screening

Where These 12-Parameter Strips Fit in Today’s Labs

Urinalysis is one of the most common diagnostic procedures in primary care, emergency rooms, and occupational health screening. For procurement teams supplying high-volume facilities, a reliable, CE-marked reagent strip with a broad parameter range can simplify inventory and reduce per-test cost. The URS-12MA from Gaobeidian PRISES targets exactly that niche — rapid multi-parameter screening in a single strip format, intended for professional in-vitro diagnostic (IVD) use.

Key application environments include clinical chemistry labs, point-of-care settings in hospitals, and private diagnostic chains where throughput matters.

Model URS-12MA at a Glance: Specs That Matter for Procurement

When shortlisting bulk urine test strips, specific technical details directly affect operational fit. Here are the specs listed for the GOLDEN TIME URS-12MA:

1. Parameters:12 built-in analytes, covering a comprehensive metabolic and urinary tract panel.
2. Reading time:1 minute — aligned with standard semi-automated readers.
3. Material & Format:PET/PLA strip; individually reactive pads.
4. Packaging:100 strips per barrel, suited for high-throughput dispensing.
5. Shelf life:2 years — a practical window for international shipping and stock rotation.
6. Power Source (listing):Categorized under “Urine Analysis System,” suggesting compatibility with reflectance photometers.
7. Device Classification:Class II (medical device), CE marked under IVD regulations.

The product is explicitly intended as a reagent strip for urinalysis, not a standalone reader — something buyers should clarify if they need integrated systems.

Supplier Snapshot: Gaobeidian PRISES Biotechnology Co., Ltd.

This manufacturer operates out of China and carries a product portfolio spanning several rapid test categories: pregnancy, ovulation, infectious diseases, drugs of abuse, and respiratory diseases. That breadth indicates in-house capabilities in lateral flow and dry chemistry reagent development, though buyers will want to confirm production scale and batch consistency for the specific URS-12MA line.

Regulatory and Quality Benchmarks

The URS-12MA ships with CE and ISO certification, essential for many import markets outside the U.S. The product falls under Class II instrument classification, and the manufacturer declares a 2-year warranty with online technical support available. No additional regional approvals (e.g., FDA 510(k), Health Canada, TGA) are indicated in the listing, so procurement teams should factor in the time and cost of supplementary registration if targeting regulated markets beyond CE recognition.

From a compliance standpoint, the listed material (PET/PLA) and IVD application are standard for dry-chemistry strips, but importers should still request a Declaration of Conformity and batch-specific QC documentation during the RFQ stage.

Next Steps for Sourcing Teams

Because this listing lacks published MOQs and tier pricing, the logical first step is a direct inquiry. Buyers should ask for:

• Wholesale price breaks and minimum order quantities (the default $2 unit may reflect sample pricing).
• OEM/private-label terms, especially if the supplier’s broader test portfolio suggests flexible branding.
• Availability of performance study data, inter-reader correlation, and sample stability reports.
• Lead times for bulk orders and packaging customization options.

Important: Verify All Claims Independently

This briefing relies solely on publicly listed product attributes. No third-party testing or audit has been performed. All specifications — including certifications, performance claims, and shelf-life data — should be validated directly with the manufacturer and, where applicable, through pre-shipment inspection or reference checks.

Buyer Checklist: 6 Points to Confirm Before Shortlisting

• Does the 12-parameter panel cover all analytes your end-users require? (Speak to clinical leads.)
• Is CE/ISO marking sufficient for your destination market, or will you need additional national approvals?
• Is the 2-year shelf life compatible with your shipping and warehousing cycle?
• Does the 1-minute read time integrate with your existing urinalysis workstations or readers?
• Can the supplier provide a full technical file, including clinical evaluation reports under IVDR where needed?
• Are you comfortable with 100 strips/barrel packing, or do you require alternative bulk packaging?

Check this SKU: Urine Test Strips Manufacturer - 12 Parameters Bulk Wholesale