Our strengths
Why laboratories choose us
From quality-controlled manufacturing to training and support, we focus on what laboratories need to work with confidence.
Quality at every stage
Every instrument is manufactured and tested under an ISO 13485:2016 quality management system.
International credentials
Quality certification, market registrations, and product documentation support international supply.
A worldwide network
Distributor partnerships connect our instruments with laboratories across Asia-Pacific, the Middle East, Africa, Latin America, and Europe.
Support within reach
Get remote installation guidance, operator training, and troubleshooting by video call, email, and messaging.
Straightforward operation
Touchscreen interfaces and guided workflows help operators get started with minimal training.
Built for the benchtop
Compact instruments with low sample and reagent consumption suit the needs of small and mid-sized laboratories.
Our company
Who we are
Sterile Safequip USA LLC is an in vitro diagnostics company with more than five years of experience supplying laboratory analyzers to healthcare and diagnostic providers worldwide.
We work in partnership with Sterile Safequip & Chemicals Limited in Ahmedabad, India. Our instruments are designed in the United States and manufactured in India under an ISO 13485:2016 quality management system.
Manufacturing & international supply
A focused range of ESR, chemistry, and coagulation analyzers, with hematology and fully automated chemistry platforms in development.
Our international distributor network supports instrument supply and connects customers with product guidance and remote technical assistance.
Meet our partner companyMission
To deliver the highest-quality in vitro diagnostic products that help laboratories and clinicians make confident decisions.
Vision
To be a global leader in IVD diagnostics, advancing healthcare through accurate, accessible, and reliable testing.
Values
Accurate, innovative diagnostics delivered with unwavering quality and ethics — improving healthcare through science, compliance, and a patient-first mindset.
IVD diagnostics
Our analyzer range
Explore the platforms behind our diagnostics portfolio, from routine sedimentation testing to clinical chemistry and hemostasis.
In development
Quality assurance
Certifications & compliance
Our quality management system, product registrations, and technical documentation provide a clear foundation for procurement and international supply.
Registered industrial design
RD 428860-001 covers the registered industrial design of ZellECHEM-PRO.
- ISO 13485:2016
- Quality management system for medical devices
- US FDA
- Establishment registration and device listing for the IVD product range
- CE
- European conformity
- CDSCO
- Central Drugs Standard Control Organisation, India
- EUDAMED
- Device data recorded in the European database on medical devices
- Health Canada
- Canadian market authorization
- RoHS
- Restriction of hazardous substances
Electrical safety & EMC standards
Instruments are tested to the following electrical safety and electromagnetic compatibility standards:
- IEC 61010-1:2010, including AMD1:2016
- IEC 61010-2-101:2018
- IEC 61326-1:2020
- IEC 61326-2-6:2020
Working with SSQLLC
Ownership & support
Test charging & consumables
Instruments use a recharge-code model: tests are charged per test, and each code carries a fixed number of tests.
- 1Purchase a recharge code online as needed.
- 2Recharge the instrument with the code’s fixed test allowance.
- 3Run tests against that allowance and recharge when required.
ZellECHEM-PRO: open system, no per-test charge
ZellECHEM-PRO operates independently of the recharge-code charging model.
Tubes, reagents, and cuvettes are supplied by Sterile Safequip or sourced locally, depending on the instrument.
Support from the first test
- 12-month instrument warranty
- Coverage starts on the date of supply and protects against manufacturing defects. Consumables and damage caused by misuse are excluded.
- Remote installation guidance
- Our team guides instrument installation remotely by video call.
- Operator training at no additional charge
- Online training helps your team understand the instrument and its routine workflows.
- Ongoing troubleshooting
- Reach our technical team by video call, email, or messaging for remote assistance.
Global Presence
Diagnostic analyzers supplied to laboratories worldwide
Our analyzers are installed and supported through distributors in the following countries and territories. Explore analyzer supply and distribution in your market.
Latin America
- Chile
- El Salvador
- Guatemala
- Brazil
- Puerto Rico
Partner with SSQLLC
Whether you are selecting an analyzer or building a distribution partnership, tell us what you need. Our team will help you take the next step.
Sterile Safequip USA LLC
1493 Burberry Lane
Schaumburg, Illinois 60173
United States