Sure-Tech Diagnostics

What Sure-Tech Diagnostics does

Sure-Tech Diagnostics (legal entity: Sure-Tech Diagnostic Associates Inc) is a privately held, specialty manufacturer of laboratory diagnostic reagents, controls, and supplies founded in 1994 and headquartered at 12115 Tesson Ferry Professional Center in Saint Louis, Missouri. The company focuses on hematology and blood-bank testing, producing Kleihauer-Betke (KB) fetal hemoglobin test kits and controls used to detect fetal-maternal hemorrhage, sickle cell test kits and quality controls for hemoglobin S detection, supporting reagents (citrate phosphate buffer, hemoglobin staining solution, red cell fixing solution, slide rinsing solution, saline), and the Hemaprep automated blood smearing instrument. Its core technology rests on validated manual assay chemistry (KB stain-and-count methodology, solubility-based sickle cell testing, and flow cytometry-compatible whole blood controls) rather than proprietary instrumentation platforms or computational methods.

The company operates a direct-to-consumer e-commerce model via a self-serve WordPress storefront at suretechdotnet.wpcomstaging.com, selling globally to clinical laboratories, hospital labs, and blood banks with publicly disclosed unit pricing ranging from $15 (pipette tips) to $795 (Hemaprep instrument). All transactions are pay-as-you-go, one-time purchases with no subscription, licensing, or enterprise contract structures documented. Revenue streams are split across diagnostic test kits, quality control consumables, laboratory equipment, general supplies, and educational materials (the Kleihauer Betke Reference Manual). The company claims its Fetal Hemoglobin test kit has become the industry standard in laboratories worldwide, supported by over 30 years of continuous operation, though it remains a micro-organization with 1-10 employees, no external investors, no documented M&A activity, and no disclosed revenue.

Name

Sure-Tech Diagnostics

Legal name

Sure-Tech Diagnostic Associates Inc

Website

https://suretechdotnet.wpcomstaging.com

Company type

Private

Founded year

1994

Operating status

Operating

Headcount range

1–10 employees

Short description

Sure-Tech Diagnostics is a privately held Saint Louis manufacturer of Kleihauer-Betke fetal hemoglobin and sickle cell diagnostic test kits, controls, reagents, and the Hemaprep blood smearing instrument, selling direct-to-consumer via its e-commerce site to clinical laboratories and blood banks worldwide.

Ownership category

akta.pro rank

Product category

Clinical Hematology Diagnostic Reagents

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

IVD Reagents, Assay Kits & Consumables (Non-instrument) (HLAHAAAM)

akta.pro secondary industries

Hematology & Coagulation Diagnostics (HLAHAAAB), Blood Bank, Transfusion Medicine & Immunohematology (HLAHAAAH), Quality Control, Calibrators, Standards & Proficiency Testing (IVD Consumables) (HLAHAAAL), Clinical Chemistry & Hematology Diagnostics (automated analyzers, blood testing) (HLAAALAH)

Keywords

• Hematology diagnostic reagents
• Fetal hemoglobin test kits
• Sickle cell testing products
• Laboratory quality controls
• Kleihauer betke assay supplies

Headquarters

HQ city

Saint Louis

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Supply Chain, Operations, Personnel, Marketing or Sales, Technology or R&D

Revenue model

1. Diagnostic Test Kits: Sale of fetal hemoglobin and sickle cell test kits in various sizes (ST 101-A, ST 101-B, ST 101-C for fetal hemoglobin; ST 301-A, ST 301-B, ST 301-C for sickle cell). These are one-time purchase reagents with multiple size options ranging from $105 to $525 depending on product type and size
2. Quality Control Products: Sale of control materials including Fetal Hemoglobin KB Controls, Sickle Cell Controls (Sickle QC), and reference standards. Controls are essential consumables for laboratory quality assurance, available in multiple concentration levels
3. Laboratory Equipment: Sale of the Hemaprep Automated Blood Smearing Instrument ($795.00), a capital equipment item for laboratory automation. This represents a higher-ticket hardware sale with potential for consumable attachments
4. Laboratory Supplies and Consumables: Sale of laboratory supplies including microscope slides, pipette tips, culture tubes, Coplin jars, buffers, staining solutions, and rinsing solutions. These are consumable products with recurring purchase potential
5. Educational Materials: Sale of the Kleihauer Betke Reference Manual in digital ($25.00) and hardcopy ($50.00) formats. Includes 20 case studies with color photographs for training technicians

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels2 records

Core offering

Sure-Tech Diagnostics manufactures and sells diagnostic test kits and reagents for hematology laboratories, primarily the Kleihauer-Betke Fetal Hemoglobin Test Kits and Sickle Cell Test Kits used to detect fetal-maternal hemorrhage and hemoglobin S. The portfolio also includes quality control materials, supporting reagents (buffers, stains, fixing solutions), the Hemaprep automated blood smearing instrument, general laboratory supplies, and a Kleihauer-Betke reference manual for technician training.

Product overview

Sure-Tech Diagnostics offers a portfolio of laboratory diagnostic products centered on fetal hemoglobin and sickle cell testing. The core offerings include Fetal Hemoglobin Test Kits (ST 101 series) and Fetal Hemoglobin KB Controls (ST 201 series), which together enable the Kleihauer-Betke assay for detecting fetal red blood cells in maternal circulation. Supporting these are specialized reagents: Citrate Phosphate Buffer, Hemoglobin Staining Solution, Red Cell Fixing Solution, and Slide Rinsing Solution. The company also provides Sickle Cell Test Kits (ST 301 series) and Sickle Cell Controls (Sickle QC, ST 401/402) for hemoglobin S detection. A key equipment product is the Hemaprep Automated Blood Smearing Instrument, which produces consistent blood smears for hematology analysis. Additional laboratory supplies include Microscope Slides, Pipette Tips, Single Channel Adjustable Volume Pippettes, Coplin Jars, Culture Tubes, and Saline Solution. Training support is offered through the Kleihauer Betke Reference Manual in both digital and hardcopy formats. The product portfolio spans diagnostic test kits, quality controls, reagents, laboratory equipment, and general supplies, serving blood banks, hematology labs, and clinical laboratories worldwide.

Differentiator

Problem solved

Functional benefit

Brands

• Hemaprep: Automated blood smearing instrument for hospitals and laboratories

Products and services

• Fetal Hemoglobin Test Kits (ST 101-A, ST 101-B, ST 101-C)

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Scale indicators3 records

Recent moves4 records

Expansion highlights4 records

Direct peers

• Streck: Streck manufactures hematology and immunology quality controls, blood bank reagents, and IVD consumables. Highly comparable as a specialty US-based manufacturer of hematology controls and laboratory reagents serving clinical labs and blood banks.
• Helena Laboratories: Helena Laboratories produces clinical electrophoresis, hemostasis, and hematology instruments and reagents. Directly comparable as a specialty manufacturer of hematology testing reagents and laboratory equipment.
• Sebia: Sebia specializes in hemoglobin electrophoresis and protein testing for clinical diagnostics. Comparable as a specialty IVD company focused on hemoglobin disorder testing including sickle cell disease screening.
• EKF Diagnostics: EKF Diagnostics manufactures point-of-care and central lab hematology analyzers, HbA1c and hemoglobin variants reagents, and clinical chemistry products. Overlaps with Sure-Tech's hemoglobin testing and hematology focus.
• Trinity Biotech: Trinity Biotech develops and manufactures IVD diagnostic kits and reagents, with a strong presence in hemoglobin testing including sickle cell and thalassemia diagnostics. Closely aligned to Sure-Tech's sickle cell and hemoglobin testing portfolio.

Emerging players

• HemoSonics: HemoSonics develops point-of-care viscoelastic hemostasis testing systems for blood banks and surgical settings. Adjacent niche player in the same hematology/coagulation testing customer base Sure-Tech serves.

Broad incumbents

• Bio-Rad Laboratories: Bio-Rad is a major global IVD manufacturer with deep hematology and clinical chemistry reagent offerings, including QC controls. A broad incumbent whose hematology controls and specialty reagents overlap with Sure-Tech's product lines.
• Beckman Coulter: Beckman Coulter (Danaher) manufactures high-volume hematology analyzers, flow cytometry systems, and reagents. A broad incumbent whose flow cytometry FMH testing directly substitutes for the Kleihauer-Betke method Sure-Tech's flagship product is built on.
• Sysmex: Sysmex is a global leader in hematology analyzers and reagents, serving the same clinical laboratory and blood bank customers as Sure-Tech. A broad incumbent offering instrument-plus-reagent systems that compete with Hemaprep and Sure-Tech's reagent portfolio.

Regional players

• Alpha Laboratories: Alpha Laboratories distributes specialty clinical diagnostics and laboratory consumables, including hematology and blood bank products, primarily across the UK and Europe. Comparable as a specialty hematology diagnostics distributor with similar customer profiles.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Sure-Tech Diagnostics