Biotech For A Better Life

POCT Analyzers, Rapid Test Kits, and IVD Raw Materials for Global Distributors

ISO 13485 and CE-certified IVD manufacturer supplying finished diagnostics and proprietary monoclonal antibody raw materials to importers and distributors in 60+ countries.

Handheld POCT Analyzers
Respiratory and Infectious Disease Rapid Tests
Blood-Borne and Tropical Disease Rapid Tests
Global (60+ countries)
60+ countries
Export markets
ISO 13485, CE, UKCA, NMPA, MHRA, MDA (Malaysia), TFDA
Certifications
3002.15 | 3822.19 | 9027.80
HS codes
High-tech Enterprise; Jiangsu Province Specialized and New Enterprise
Enterprise status
Global (60+ countries)
ISO 13485CEUKCAMDA (Medical Device Authority Malaysia)NMPAMHRATFDAHigh-tech Enterprise CertificationJiangsu Province Specialized, Specialized and New Enterprise

Supplier-declared, pending confirmation

Product Categories

Handheld POCT Analyzers

Compact portable analyzers covering biochemistry, immunoassay, dry chemistry, urine, and hematology, results in 0.5 to 15 minutes.

  • BK120 Dual-methodology Handheld Analyzer (dry chemistry + immunofluorescence, 150+ test items, 750 g)
  • BK160 Hematology Analyzer (21 parameters, liquid-free, single-use reagent, 2 kg)
  • BK150 Handheld Urine Analyzer (14 items in 60 seconds, 360 g)
  • BK100 Handheld Dry Chemistry Analyzer (Bluetooth, 230 g, result in 0.5, 10 min)

Respiratory and Infectious Disease Rapid Tests

Lateral-flow and immunochromatographic assay kits for respiratory pathogens, each supplied in 25-test packs with nasopharyngeal swab collection.

  • SARS-CoV-2 Antigen Rapid Detection Kit (self-test and professional use)
  • Influenza A and B Antigen Rapid Test Kit
  • SARS-CoV-2 + Influenza A/B + RSV + Adenovirus 4-in-1 Combo Kit
  • Group A Streptococcus Antigen Test Kit

Blood-Borne and Tropical Disease Rapid Tests

Whole blood, serum, or plasma lateral-flow kits for HIV, hepatitis, syphilis, dengue, malaria, and typhoid, including multi-marker combo formats.

  • HIV 1/2, HCV, HBsAg, and Syphilis 4-in-1 Combo Kit
  • Dengue IgG/IgM/NS1 Combo Rapid Test Kit
  • Malaria HRP2/pLDH (P.f/P.v) Antigen Rapid Test Kit
  • HAV IgG/IgM, HBsAg, and HCV individual kits

Oncology and Cardiac Marker Rapid Tests

Serum, plasma, or whole blood lateral-flow kits for cancer screening antigens and cardiac biomarkers, with 25 tests per kit.

  • AFP (Alpha-Fetoprotein) Rapid Test Kit
  • CEA (Carcinoembryonic Antigen) Rapid Test Kit
  • tPSA and fPSA Rapid Test Kits
  • Cardiac Troponin I Rapid Test Kit

Gastro, Reproductive, and General Screening Tests

Rapid tests covering gastrointestinal infection markers, reproductive hormones, and fecal screening, lateral-flow and immunochromatographic formats.

  • H. Pylori Antigen (feces) and Antibody (blood) Rapid Test Kits
  • Calprotectin (CAL) Rapid Test Kit
  • Fecal Occult Blood (FOB) Rapid Test Kit
  • HCG and LH Ovulation Test Kits

IVD Raw Materials and Antigens/Antibodies

Proprietary monoclonal antibody raw materials, antigens, and detection reagents supplied to IVD developers and kit manufacturers.

  • Monoclonal antibodies for IVD development
  • Antigen raw materials
  • Detection reagents and conjugates

Why Source from Bioantibody

Full value chain under one roof

Bioantibody manufactures proprietary monoclonal antibody raw materials and uses them directly in finished rapid test kits and POCT instruments, giving buyers a single-source supplier from raw material to finished device.

Regulatory clearance across major markets

Products hold ISO 13485, CE, UKCA, NMPA, MHRA, MDA (Malaysia), and TFDA certification, reducing the regulatory burden for distributors entering regulated markets.

Broad instrument portfolio, compact form factors

POCT analyzers range from 230 g (BK100 dry chemistry) to 2 kg (BK160 hematology), covering biochemistry, immunoassay, urine, and hematology in devices suited for decentralized and point-of-care settings.

Extensive rapid test menu depth

The lateral-flow kit catalogue spans infectious disease, oncology markers, cardiac biomarkers, and reproductive health, including multi-analyte combo formats covering up to four pathogens in a single test.

Established global distribution footprint

Products are supplied to importers and distributors in 60+ countries, supporting established logistics and regulatory documentation processes for international orders.

Sourcing FAQ

Is Bioantibody a manufacturer or a trading company?

Bioantibody is a manufacturer. The company produces IVD instruments, lateral-flow rapid test kits, and monoclonal antibody raw materials at its own facilities and holds High-tech Enterprise status in Jiangsu Province, China.

Which regulatory certifications do the products carry?

Products are certified under ISO 13485, CE (EU), UKCA (United Kingdom), NMPA (China), MHRA (United Kingdom), MDA (Malaysia), and TFDA (Taiwan). Specific certifications vary by product; confirm applicability for your target market when requesting a quote.

Which markets does Bioantibody currently export to?

Bioantibody supplies distributors and importers in 60+ countries across multiple regions. Contact the sales team to confirm product availability and documentation for your specific country.

What HS codes apply to these products?

The primary HS codes are 3002.15 (monoclonal antibodies and related biological products), 3822.19 (diagnostic reagents and kits), and 9027.80 (instruments for physical or chemical analysis). Confirm the correct code with your customs authority for the final imported product.

Can Bioantibody supply IVD raw materials as well as finished kits?

Yes. In addition to finished rapid test kits and POCT instruments, Bioantibody supplies proprietary monoclonal antibodies, antigens, and detection reagents to IVD developers and kit manufacturers seeking raw material inputs.

How do I request pricing or product samples?

Use the pricing request form on this page to describe your product interest, target market, and estimated volumes. The Bioantibody sales team will respond with product specifications, pricing, and sample arrangements.

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