Product Specifications
|
Parameter |
Specification |
|
Product Type |
Upper and lower injection-molded rapid-test cassette shells with matching plastic components |
|
Reference Cassette Sizes |
70 × 20 × 5.5 mm; 82 × 25 × 4.7 mm; 70 × 32 × 6.3 mm; 70 × 40 × 6.0 mm |
|
Compatible Test Strip |
3.0–4.0 × 60 mm single-strip formats |
|
Material Options |
Medical-grade PP, PC, or COC |
|
Critical Mold Accuracy |
±0.01 mm |
|
Assembly Fit Tolerance |
<0.10 mm; strip-positioning features controlled within 0.05 mm |
|
Closure Options |
Snap, screw, or flip closure |
|
Temperature Resistance |
PP configuration up to 121°C |
|
Identification |
Pad printing, screen printing, laser marking, barcode, or QR code |
|
Supply Condition |
Non-sterile paired shells or separated molded components |
|
Sample Lead Time |
7–10 days after drawing and material confirmation |
Key Advantages
● Controlled Strip And Window Positioning
Strip channels, locating ribs, and the read window are molded to the approved drawing. They keep the membrane in line with the viewing area during manual or automated assembly and help prevent the strip from shifting after the cassette is closed.
● Stable Sample-Well And Closure Geometry
The sample port, internal flow area, snaps, and perimeter fit are designed together. This geometry directs dispensed liquid toward the strip and reduces leakage caused by an uneven fit between the upper and lower shells.
● Consistent Surfaces For Assembly And Identification
Gate location, ejector layout, color, and visible surfaces are controlled in the handling and marking areas. The resulting consistency helps parts sit correctly in assembly fixtures and supports clear printing, camera inspection, and visual defect checks.
Customization Options
● Cassette Configuration
Overall cassette size, sample-well geometry, and strip-to-window alignment are set to the assay design.
● Resin And Appearance
Resin grade, opacity, and color are selected according to reagent-contact and visual-reading requirements.
● Identification And Packing
Identification may be molded or printed. Components can be packed as paired sets or separated parts to suit the approved assembly method.
Customization Process
Requirement Definition
Confirm the assay format, strip dimensions, and supplied design data.
DFM Review
Finalize the wall structure, snap fit, and tolerance-critical interfaces.
Tool Development
Build the mold to the approved cavity plan and component configuration.
T1 Verification
Check strip position, sample-well alignment, and shell closure with the reference parts.
Production Approval
Approve the molded sample, resin specification, and stable molding window.
Production Handover
Release the approved tool, work instructions, and reference sample to scheduled production.
Quality Control
● Material Traceability
Production records identify the resin grade and lot used for each batch. No material substitution is allowed without written approval.
● Critical Interface Inspection
Inspection covers the strip channel, sample-well position, and fit between the upper and lower shells, using the approved control plan.
● Cleanliness And Appearance
Before packing, each part is visually inspected for contamination and molding defects.
FAQ
Q1: What is the MOQ for a custom Medical Test Kit?
A1: MOQ is based on one standard container. The final piece count is calculated from cassette dimensions, cavity output, and the approved export packing density.
Q2: What are the payment terms for a custom project?
A2: The tooling fee is paid in advance, followed by the product deposit. For EXW or FOB orders, the balance is due after the container is loaded and sealed. For CIF orders, it is due before release of the bill of lading.
Q3: Are the molded test-kit components supplied sterile?
A3: Standard supply covers non-sterile molded components. Sterilization, sterile-barrier packaging, and validation require a separate controlled process.
Q4: How is compatibility with assay buffers or reagents confirmed?
A4: Compatibility work starts with the reagent composition, concentration, contact time, and storage condition. Material candidates and molded samples can then be tested under the assay developer's compatibility and aging protocol.
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