About Core Technology Co., Ltd. - Diagnostic Kits Supplier in China

Core Technology Co., Ltd. is based in China and currently lists seven active products in its catalogue. The portfolio is confined to in‑vitro diagnostic rapid test kits, specifically ovulation, pregnancy (hCG), HIV‑1/2, malaria, hepatitis B surface antibody and a combined HCG pregnancy kit. All seven items fall under HS chapter 38, code 3822.00, which covers diagnostic or laboratory reagents, including immunochromatographic devices. The products are built on nitrocellulose membranes coupled with monoclonal antibodies or recombinant antigens and are housed in plastic casings of ABS, PP or PS. The catalogue does not provide additional manufacturing details beyond the listed materials.

The supplier classifies the items under the top categories “Diagnostic Kits” and “Rapid Test Kits”. Each entry is described as a lateral‑flow immunoassay, using colloidal gold or latex conjugates for visual read‑out. The HCG and pregnancy kits mention CE marking, indicating conformity with European health‑device directives. The HIV‑1/2 and malaria kits employ recombinant antigens and gold nanoparticles, typical of WHO‑recommended rapid diagnostic tests. The hepatitis B surface antibody test uses immobilised recombinant HBsAg antigen on a plastic lateral flow device. No HS codes other than 3822.00 are listed for individual products.

Product Range and Specialties of Core Technology Co., Ltd.

The catalogue covers seven lateral‑flow immunochromatographic devices that target hormones, pregnancy, viral antigens and malaria parasites. In the IVD market, rapid tests are commonly graded by clinical sensitivity and specificity, with CE‑marked products typically achieving ≥95 % sensitivity and ≥98 % specificity. Nitrocellulose membranes are selected for pore sizes between 8 - 12 µm, and colloidal gold particles of 20 - 40 nm give the characteristic red line. Plastic housings are usually injection‑moulded ABS or PP, providing chemical resistance and a 10‑year shelf life when stored at 2‑30 °C. Buyers often request ISO 13485 certification for the manufacturing quality system and a performance validation report that includes limit of detection, cross‑reactivity and stability data.

Trade and Export Information - Core Technology Co., Ltd.

China is one of the world’s largest exporters of in‑vitro diagnostic rapid test kits, and products classified under HS 3822.00 are routinely shipped to Europe, North America, the Middle East and Southeast Asia. Importers generally require CE marking for the European market, FDA 510(k) clearance or EUA for the United States, and ISO 13485 compliance for quality management. Standard packaging consists of individual kits sealed in moisture‑barrier pouches, grouped into cartons of 100‑500 units, and loaded into 20‑ft or 40‑ft containers using FOB Shanghai or CIF destination terms. Export documentation typically includes a commercial invoice, packing list, certificate of origin and any applicable test reports. Chinese manufacturers of lateral‑flow devices often operate under the supervision of the China Food and Drug Administration (CFDA), which aligns with international IVD regulations.

Sourcing from Core Technology Co., Ltd. - Buyer Guidance

When sourcing rapid test kits from Core Technology, buyers should request the latest CE declaration of conformity and any ISO 13485 certificates that cover the production line. Performance data such as sensitivity, specificity, limit of detection and stability at defined temperature and humidity ranges should be provided in a validated test report. It is advisable to obtain a pre‑production sample for independent verification and to confirm the packaging dimensions, moisture barrier specifications and expiry dating. Verify that the HS code 3822.00 is correctly declared on shipping documents and that the product labeling meets the regulatory language requirements of the target market.

What product categories does Core Technology offer?

The supplier lists seven rapid test kits covering ovulation, hCG pregnancy, HIV‑1/2, malaria, hepatitis B surface antibody and a combined HCG pregnancy kit, all classified under HS code 3822.00.

Which material technologies are used in these kits?

All kits employ nitrocellulose membranes as the immunochromatographic strip, with monoclonal antibodies or recombinant antigens, and use colloidal gold or latex conjugates; the housing is injection‑moulded plastic (ABS, PP or PS).

What certifications should a buyer verify for these IVD products?

Buyers should request the CE declaration of conformity, ISO 13485 quality‑system certification, and, for markets such as the United States, any FDA 510(k) or Emergency Use Authorization documentation.

What are the typical minimum order quantities and lead times?

Suppliers of lateral‑flow kits often set MOQs between 5 000 and 10 000 units per SKU, with production lead times of 30‑45 days after sample approval, though exact figures must be confirmed with the supplier.

How are the kits packaged for export?

Each test is sealed in a moisture‑barrier pouch, packed into cartons of 100‑500 kits, and the cartons are loaded on standard 20‑ft or 40‑ft containers; pallets are shrink‑wrapped for stability during transit.

Which HS code is applicable for customs clearance?

All seven products are listed under HS code 3822.00, the heading for diagnostic or laboratory reagents, including immunochromatographic test kits.

What documentation is required for customs in importing countries?

Typical documents include a commercial invoice, packing list, certificate of origin, CE declaration, and any test reports or regulatory approvals required by the destination authority.

How can a buyer request a sample?

Buyers should contact the supplier with the specific SKU, request a pre‑production sample, and ask for accompanying performance data and material safety data sheets before placing a bulk order.