What r2 Diagnostics does

r² Diagnostics Inc. is a privately held, FDA 21CFR820-registered and ISO 13485:2016-certified manufacturer of hemostasis diagnostic reagents and quality-control plasmas for clinical coagulation laboratories. Founded in 1993 in South Bend, Indiana, as a sister company to Enzyme Research Laboratories (ERL), the company controls its production pipeline end-to-end — sourcing high-purity coagulation proteins, zymogens, and human thrombin from ERL and converting them into finished diagnostic kits. Its product portfolio spans the coagulation cascade, including Phosphoplastin RL (low-ISI liquid thromboplastin for PT assays), Phospholin ES (heparin- and lupus-sensitive APTT reagent), the LupoTek family of DRVVT-based lupus anticoagulant tests, ThromboTek PSe for Protein S, FibroTek and T-Tek for fibrinogen and thrombin time, NoFact VIII/IX immunodepleted plasmas for factor assays, and a 2025-launched Emicizumab Calibrator and Controls line for hemophilia A therapeutic drug monitoring. Most products carry both 510(k) clearance for the US and CE marking for Europe.

The company sells through direct field sales inside the United States and through an established network of regional distributors across Europe, Asia-Pacific, the Middle East, Africa, and Latin America, supplemented by a wholly-owned Indian subsidiary (R² Hemostasis Diagnostics India Private Ltd) serving the SAARC region. Pricing is quote-based for all SKUs with no public list pricing. The customer base consists of hospital and independent clinical coagulation laboratories performing routine hemostasis screening and specialty thrombophilia, lupus anticoagulant, and factor assays; no named end-customer accounts or enterprise contracts are disclosed. Marketing is primarily educational, anchored in references to ISTH, ECAT, NASCOLA, and peer-reviewed hemostasis literature.

r² Diagnostics has no disclosed venture or growth equity funding, no M&A history, and operates as part of the closely affiliated ERL family of companies. The business is profitable-by-inference given its 30-year operating history and stable distributor footprint, but no revenue, headcount growth, or margin figures are available. The strategic posture is that of a steady, owner-operated specialty IVD manufacturer that periodically extends its portfolio (most recently into emicizumab monitoring) and incrementally broadens its international channel reach.

Name

r2 Diagnostics

Legal name

r² Diagnostics Inc.

Website

https://r2diagnostics.com

Company type

Private

Founded year

1993

Operating status

Operating

Headcount range

101–250 employees

Short description

r² Diagnostics is a privately held, FDA- and ISO 13485-certified manufacturer of hemostasis diagnostic reagents and control plasmas, serving clinical coagulation laboratories in the US and 20+ countries via direct sales and regional distributors.

Ownership category

akta.pro rank

Product category

Hemostasis Diagnostic Reagents

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical Equipment and Supplies Manufacturing (3391)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Wholesale-Medical, Dental & Hospital Equipment & Supplies (5047)

akta.pro primary industry

Hematology & Coagulation Diagnostics (HLAHAAAB)

akta.pro secondary industry

Clinical Chemistry & Hematology Diagnostics (automated analyzers, blood testing) (HLAAALAH)

Keywords

• Hemostasis diagnostic reagents
• Coagulation laboratory products
• Plasma control reagents
• Lupus anticoagulant testing
• Fibrinogen assay kits

Headquarters

HQ city

South Bend

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Diagnostic Reagent Sales: Sale of hemostasis diagnostic reagents including PT, APTT, and specialized coagulation assays to clinical laboratories
2. Control Plasma Products: Sale of quality control plasmas (PlasmaCon N, L1, L2, LA) for internal QC programs in clinical coagulation laboratories
3. Emicizumab Calibration/Control Products: Sale of emicizumab calibrators and controls for monitoring hemophilia A patients treated with emicizumab

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels3 records

Core offering

r² Diagnostics manufactures and distributes hemostasis diagnostic reagents, plasma controls, calibrators, and specialty coagulation kits for clinical coagulation laboratories. Its portfolio covers routine PT and APTT assays, lupus anticoagulant detection, fibrinogen and thrombin time testing, protein S assays, immunodepleted factor plasmas, and emicizumab therapeutic drug monitoring, produced with end-to-end manufacturing control in partnership with sister company Enzyme Research Laboratories (ERL).

Product overview

r2 Diagnostics is an FDA 21CFR820 registered and ISO 13485 certified manufacturer of hemostasis diagnostic products for clinical coagulation laboratories. The company offers a comprehensive portfolio of routine reagents (Phosphoplastin RL for PT assays, Phospholin ES for APTT assays), plasma controls (PlasmaCon N/L1/L2 for QC, PlasmaCon LA for lupus anticoagulant testing), specialty coagulation reagents (ThromboTek PSe for Protein S, LupoTek product line for lupus anticoagulant detection including Detectin VL, Correctin VL, and KCT), fibrinogen reagents (FibroTek and T-Tek using human thrombin from sister company Enzyme Research Labs), immunodepleted plasmas (NoFact VIII and IX), and emicizumab calibrators/controls for therapeutic drug monitoring. The products are manufactured with end-to-end control over materials and processes, incorporating high-purity proteins from Enzyme Research Laboratories. Most products are available with both 510(k) and CE regulatory classifications.

Differentiator

Problem solved

Functional benefit

Products and services

• Phosphoplastin RL Liquid thromboplastin reagent with ISI less than 1.2 for one-stage Prothrombin Time (PT) assays, used for screening coagulopathies, monitoring warfarin therapy, and diagnosing DIC and factor inhibitors on automated coagulation analyzers.
• Phospholin ES Heparin and lupus sensitive ellagic acid APTT reagent with 25mM calcium chloride, used for screening intrinsic/contact pathway deficiencies, monitoring heparin therapy, and detecting lupus anticoagulants and factor inhibitors.
• PlasmaCon N, L1, and L2 Control Plasmas Normal (N), mildly abnormal (L1), and highly abnormal (L2) assayed control plasmas used in clinical laboratories to monitor the performance of PT and APTT tests within internal quality control programs.
• PlasmaCon LA LA-positive abnormal control plasma used to monitor performance of lupus anticoagulant diagnostic assays in clinical coagulation laboratories.
• Emicizumab Calibrator Plasma calibrator at 100 ug/mL emicizumab used to calibrate the modified one-stage FVIII activity assay for determining active emicizumab concentration from clot time measurement on automated coagulation analyzers, supporting therapeutic drug monitoring for hemophilia A patients.
• Emicizumab Controls Assayed plasma controls at Level 1 (25 ug/mL) and Level 2 (75 ug/mL) for quality control of modified one-stage FVIII activity assays used to determine active emicizumab concentration in patient samples.
• NoFact Immunodepleted Plasmas (Factor VIII and Factor IX) Human plasma pools selectively depleted of single coagulation factors (Factor VIII or Factor IX) by immunoadsorption, used as substrate-deficient plasmas for quantitative factor activity assays in clinical coagulation laboratories.
• ThromboTek PSe Complete kit for quantitative determination of Protein S activity in human plasma by clotting assay, with 24-hour reconstituted stability, used for thrombophilia testing in clinical coagulation laboratories.
• LupoTek Detectin VL and LupoTek Correctin VL Vipera lebetina venom-based screening (Detectin VL) and high phospholipid confirmatory (Correctin VL) reagents for lupus anticoagulant detection using the dilute Russell's viper venom (DRVVT) methodology on clinical coagulation analyzers.
• LupoTek KCT Kaolin-activated clotting time reagent optimized for automated coagulometers, used as a screening assay for lupus anticoagulants and antiphospholipid antibodies.
• T-Tek Thrombin Time Reagent Thrombin reagent containing human thrombin (from Enzyme Research Laboratories) for quantitative determination of Thrombin Time in citrated human plasma, used to detect heparin presence and fibrinogen abnormalities.
• FibroTek Fibrinogen Kit Complete Clauss assay kit for quantitative determination of fibrinogen in citrated human plasma using purified human thrombin (100 NIH units), used in the diagnosis of DIC, liver failure, and fibrinogen abnormalities.

Quantifiable outcome

• Low ISI < 1.2 for Phosphoplastin RL providing sensitive PT testing
• +2 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature10 records

Partnerships

Two partnerships are on record, tiered core and minor.

• Enzyme Research Laboratories (ERL)coreStrategic or Co-development PartnerEnzyme Research Laboratories is a sister company and key strategic partner of r² Diagnostics. ERL manufactures high purity proteins and reagents of the coagulation and fibrinolytic pathways which r² Diagnostics incorporates into clinical diagnostic kits. ERL is known worldwide for purified coagulation factors and research reagents including zymogens, activated enzymes, monoclonal and polyclonal antibodies, and immunodepleted plasmas. r² Diagnostics was organized specifically to incorporate ERL's high purity proteins into diagnostic products with end-to-end control.
• Enzyme Research Laboratories Ltd (UK)minorChannel Partner/ Reseller/ DistributorUK-based subsidiary of Enzyme Research Laboratories serves as distributor for r² Diagnostics products in Ireland and United Kingdom markets.

Scale indicators3 records

Recent moves5 records

Expansion highlights4 records

Direct peers

• Diagnostica Stago: Privately held French IVD company and the leading pure-play hemostasis specialist; manufactures coagulation reagents and analyzers across routine, specialty, and lupus anticoagulant testing — directly comparable scope to r² Diagnostics' reagent portfolio.
• Werfen (Instrumentation Laboratory / IL): Spain/US-based diagnostics division focused on hemostasis (ACL series analyzers and Hemochron) along with critical-care and autoimmunity; competes head-to-head with r² in coagulation reagent markets served by global distributors.
• Sekisui Diagnostics: Japan/US specialty diagnostics firm offering coagulation reagents for routine and specialty testing, including lupus anticoagulant and factor-deficient plasmas — directly comparable scope and customer base to r² Diagnostics.
• Trinity Biotech: Ireland/US-listed specialty diagnostics company with a hemostasis product line (including Coagulation and Infectious Disease offerings), targeting similar clinical and specialty coagulation laboratory customers as r².
• Helena Laboratories: Privately held US specialty IVD manufacturer offering coagulation reagents, hemostasis controls, and specialty assays; comparable mid-size profile and customer focus to r² Diagnostics.
• HYPHEN BioMed: French specialty hemostasis reagent developer with deep lupus anticoagulant and thrombophilia assay expertise now operating within the Stago group; competes with r²'s LupoTek and specialty hemostasis franchises.

Broad incumbents

• Siemens Healthineers: Diversified diagnostics giant offering hemostasis reagents and Sysmex-derived coagulation analyzers (formerly Dade Behring) to clinical laboratories globally; competes with r² across PT/APTT/specialty reagent categories as part of a much broader menu.
• Roche Diagnostics: Global IVD major with cobas hemostasis reagent lines and integrated analyzer platforms; broader portfolio and instrument-installed-base advantage over r² in routine coagulation testing.
• Abbott Diagnostics: Multi-specialty diagnostics company with hemostasis reagents sold through its core laboratory franchise; competes with r² in clinical coagulation laboratories but bundles reagents with much wider instrument and assay portfolios.

Emerging players

• Hart Biologicals: UK-based smaller specialist in coagulation reagents and quality control plasmas; similar product mix to r² including lupus anticoagulant controls and factor-deficient plasmas, serving a comparable laboratory customer base at sub-incumbent scale.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries1 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 r2 Diagnostics