Name: China Drug Abuse Test For In Vitro Diagnostic Use Only Manufacturers Suppliers Factory - Lysun
Brand: Lysun
SKU: 309217485

Product Overview & IVD Regulatory Value

The Drug Abuse Test For In Vitro Diagnostic Use Only panel stands as a premier medical-grade screening asset designed for professional clinical toxicology, rehabilitative medicine, and legal forensic diagnostics. Manufactured by Hangzhou Lysun Biotechnology under strict ISO 13485 medical quality management systems, this lateral flow immunochromatographic assay is explicitly intended for the qualitative evaluation of multiple drug metabolites from human urine.

The professional IVD labeling guarantees that the device fulfills critical laboratory cross-reactivity and precision cut-off metrics required by healthcare institutions, separating it from low-grade novelty options. This empowers hospitals, centralized laboratories, and specialized clinics to establish rapid, legally compliant patient triaging and treatment protocols within 5 minutes, eliminating the operational delays of initial heavy laboratory instrumentation worldwide.

Key Performance, Formats & Clinical Presentations

Versatile Manufacturing Configurations: Available in both cost-effective testing strips for large-scale screenings and enclosed diagnostic cassettes to suit different clinical environments and preferences.
Precise Matrix Calibration: Optimized exclusively for human urine specimens, utilizing high-purity gold conjugates to ensure sharp visual color developments at the test (T) line with low analytical background noise.
Clinical Pack Efficiency: Presented in our standard commercial 25 tests per box configuration, with each test individually vacuum-sealed in barrier foil pouches with micro-droppers to minimize room-temperature contamination.

B2B Sourcing, Wholesale & Factory-Direct Advantage

As an established, integrated manufacturing and trade factory, we provide a reliable, low-overhead international supply chain for medical wholesalers and laboratory suppliers.

Aggressive Factory-Direct Costing: By sourcing directly from our Hangzhou facility, international medical buyers bypass secondary agent markups to unlock elite wholesale pricing as low as fractions of a dollar per test.
Guaranteed 1-2 Weeks Lead Time: We operate an on-demand manufacturing system instead of storing stale inventory. Your bulk orders are fully verified and cleared for dispatch within a tight 1-2 weeks window, ensuring your distribution network receives pristine lots with maximum remaining shelf stability.
Risk-Free Trial Collaboration: We actively support market validation by allowing flexible, lower quantities on your first shipment, removing strict MOQ limitations for initial laboratory evaluations.

Product name	AMP Rapid Test Self-Test
Item type	AMP-U11, AMP-U21
Specimens	Urine
Packing Specification	25 kits/ box
Shelf life	2 years
Test Time	Waiting about 5 minutes
Certificate	CE, ISO:13485
OEM	Acceptable
Storage condition	The kit should be stored at 2-30°C

PROCEDURE

Bring tests, specimens, and/or controls to room temperature (15-30°C or 59-86°F) before use.

1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. For best results, the assay should be performed within one hour.

2. Take off the cap outside of the test end. With arrows pointing toward the urine specimen, immerse the test panel vertically into the urine specimen for at least 10-15 seconds. Immerse the test panel to at least the level of the wavy lines on the strip(s), do not pass the arrows on the test panel when immersing the panel.

3. Place the test panel on a non-absorbent flat surface, start the timer and wait for the red line(s) to appear. The results should be read at 5 minutes. Do not interpret results after 10 minutes.

Bring tests, specimens and/or controls to room temperature (15-30°C) before use.

1. Remove the test from its sealed pouch and use it as soon as possible. To obtain a best result, the assay should be performed within one hour.

2. Hold the strip at the handle with the product name imprints. Do not touch the membrane part of the strip to avoid contamination.

3. Dip the test strip vertically in the urine specimen for at least 10-15 seconds. Do not pass the maximum line (MAX) on the test strip when

immersing the strip. As the test begins to work, you will see color move across the membrane.

4. Take the strip out of the specimen afterwards and place it on a non-absorbent flat surface. Start the timer and wait for the colored line(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 20 minutes.

QUALITY CONTROL

Bring tests, specimens and/or controls to room temperature (15-30°C) before use.

Remove the test from its sealed pouch and use it as soon as possible. To obtain a best result, the assay should be performed within one hour.

Hold the strip at the handle with the product name imprints. Do not touch the membrane part of the strip to avoid contamination.

Dip the test strip vertically in the urine specimen for at least 10-15 seconds. Do not pass the maximum line (MAX) on the test strip when immersing the strip. As the test begins to work, you will see color move across the membrane.

Take the strip out of the specimen afterwards and place it on a non-absorbent flat surface. Start the timer and wait for the colored line(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 20 minutes.

FAQ

Q: Does this Drug Abuse Test carry the explicit 'For In Vitro Diagnostic Use Only' labeling on the packaging?

A: Yes. Every commercial lot manufactured by Hangzhou Lysun Biotechnology features clear regulatory markings on the outer box, inner foil pouches, and package insert, ensuring complete compliance for professional medical and laboratory audits.

Q:Can we mix both strip and cassette formats into a single initial order, and what is the MOQ restriction?

A: While our standard mass production reorder structure starts at a manageable 500 units per lot, we actively accommodate regional market testing by allowing lower quantities and flexible format blending on your initial shipment with no strict MOQ limits.

Q: What is the packaging standard for hospital and clinical laboratory procurement?

A: Our standard commercial configuration is a clinical-grade 25 tests per box presentation. Each kit includes individually sealed foil pouches with the target diagnostic device and disposable capillary droppers to ensure maximum sanitary handling during urine processing.

Q: How does your on-demand manufacturing model benefit international IVD distributors regarding shelf life?

A: Because we run a comprehensive integrated manufacturing and trade operation, we eliminate stagnant warehouse stock. Your batch is produced fresh on-demand, meaning your supply chain receives products with a maximized 24-month shelf life directly from the production line.

Q:What are your payment and shipping logistics options for container-level bulk purchasing?

A: We offer absolute logistical flexibility. We fully support your designated freight forwarder from any departure port of your choice; alternatively, we can utilize our partnered lines, which typically route via high-efficiency Shenzhen customs transferring through Hong Kong hubs for fast air and sea dispatch.

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Drug Abuse Test For In Vitro Diagnostic Use Only

PROCEDURE

QUALITY CONTROL

FAQ

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