# Bioantibody Biotechnology Co., Ltd.

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.

- Canonical: https://catalog.reevol.com/p/marketing/bioantibody-biotechnology-co-ltd
- Language: en
- Last updated: 2026-08-26

## Supplier facts

- Supplier type: manufacturer
- Export markets: Global (60+ countries)
- HS codes: 3002.15, 3822.19, 9027.80
- Product categories: In Vitro Diagnostic (IVD) Raw Materials, Rapid Test Kits, Quantitative Test Kits, Handheld Diagnostic Analyzers, Antigens & Antibodies, Detection Reagents, In Vitro Diagnostics (IVD), POCT Instruments, Biochemical Analyzers, Immunoassay Analyzers, Urine Analyzers, Hematology Analyzers, Infectious Disease Testing, Oncology Markers, Cardiovascular Diagnostics, IVD Raw Materials and Reagents
- Enterprise status: High-tech Enterprise; Jiangsu Province Specialized and New Enterprise

## Certifications

- ISO 13485: supplier-declared, pending confirmation
- CE: supplier-declared, pending confirmation
- UKCA: supplier-declared, pending confirmation
- MDA (Medical Device Authority Malaysia): supplier-declared, pending confirmation
- NMPA: supplier-declared, pending confirmation
- MHRA: supplier-declared, pending confirmation
- TFDA: supplier-declared, pending confirmation
- High-tech Enterprise Certification: supplier-declared, pending confirmation
- Jiangsu Province Specialized, Specialized and New Enterprise: supplier-declared, pending confirmation

## Product Categories (6)

### 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

## 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.

## Contact

- Inquiry endpoint (POST form): https://catalog.reevol.com/api/marketing/inquiry/bioantibody-biotechnology-co-ltd
