IVD reagents · R&D / Manufacturing / Service

In vitro diagnostics · Making every test more reliable

Precision reagents,
guarding every diagnosis

HEMANOVA specializes in the R&D and manufacturing of in vitro diagnostic reagents, covering clinical chemistry, immunoassay, molecular, coagulation and QC platforms, delivering stable and traceable testing solutions for laboratories worldwide.

  • 150+ registered products
  • 3,000+ partner laboratories
  • Service network in 28 provinces
HEMANOVA in vitro diagnostic reagents and laboratory platform illustration
ISO 13485Quality management system
Full lot traceabilityFrom raw materials to release
Quality & Compliance
  • NMPA registered products
  • ISO 13485
  • ISO 9001
  • CE certified
  • National high-tech enterprise
2012

Founded

150+

Registered products & pipeline projects

3,000+

Partner institutions & laboratories

28provinces

National service network coverage

Featured Products

Key products

Focused on infection, cardiovascular, respiratory and thrombosis testing, delivering stable, traceable reagents clinicians can rely on.

HEMANOVA R&D laboratory and testing equipment illustration
14 yearsfocused on in vitro diagnostics
About HEMANOVA

Reliable reagents,
connecting laboratories and clinics

Founded in 2012, HEMANOVA Biotech (Shanghai) Co., Ltd. is headquartered in Zhangjiang, Shanghai, with an R&D and manufacturing base in Suzhou. We focus on the development, production and technical service of in vitro diagnostic reagents, making high-quality test results more accessible.

We have built five technology platforms — clinical chemistry, chemiluminescence, molecular PCR, coagulation and QC calibration. Our products serve 28 provincial-level regions across China and markets in Southeast Asia, the Middle East and Europe. From raw material selection to product release, systematic quality management ensures the consistency of every batch.

Independent R&DIn-house control of key raw materials and formulations
Stable supplyAutomated production lines and cold-chain logistics
Full traceabilityComplete lot, QC and release records
Professional serviceApplication training and technical support teams
Inside HEMANOVA
Quality & Manufacturing

Quality,
a consistent promise in every batch

We organize R&D, production and service under the ISO 13485 medical device quality management system. Formulation, filling and packaging take place in ISO Class 8 cleanrooms, and incoming material inspection, process control, finished product release and retained-sample stability studies together build quality assurance across the product life cycle.

Class 100kcleanroom production
100%finished batches retained
2–8°Ccold-chain storage & transport
24hquality issue response

Systematic quality management

End-to-end control across design, purchasing, production, release and post-market surveillance.

Smart manufacturing

Automated formulation and filling lines with real-time recording and trend analysis of critical parameters.

Full traceability

Raw material lots, production records and test data are linked, so issues can be quickly located and closed out.

Supply chain assurance

Dual sourcing and safety stock for key raw materials, with cold-chain logistics for reliable delivery.

How We Work

From requirement to delivery, every step has a standard

01

Needs & solutions

Our application team reviews your assay menu, sample volume and platform requirements, then recommends a product mix and validation plan.

02

Validation & training

We support method validation, reference interval confirmation and staff training to establish standardized workflows.

03

Stable supply

Lot management and cold-chain logistics secure delivery, with appropriate safety stock for key products.

04

Ongoing support

QC data reviews, technical follow-ups and rapid response mechanisms continuously support laboratory quality improvement.

Newsroom

News & updates

Follow HEMANOVA's product progress, quality practices and industry activities.

Product news
2026-09-18

New-generation chemiluminescence platform officially launched

The CL series platform for mid- to large-sized laboratories has been upgraded with further improvements in throughput, reagent loading and end-to-end traceability.

Company news
2026-08-06

Annual ISO 13485 quality management system audit passed

The audit covered design, purchasing, production, quality control and post-market surveillance; the auditors affirmed our system performance.

Exhibitions
2026-07-12

At China International Laboratory Medicine Expo 2026

Presenting four product lines — chemistry, immunoassay, molecular and coagulation plus QC — and exchanging views on standardized testing with laboratories.