What RNA Medical does

RNA Medical is a developer and supplier of quality control materials, calibration verification controls, and specialty blood collection products for the in-vitro diagnostics market, operating as a trademark of Bionostics, Inc., which is itself a subsidiary of Bio-Techne Corporation. The company is headquartered at a single GMP manufacturing facility in Devens, MA, and sells a focused catalog of assayed QC products covering blood gas, electrolyte, metabolite, BUN, CO-Oximetry, and hemoglobin parameters (e.g., QC 823, CC 527, QC 253, CVC 123, CVC 223, QC HGB), Mylar-wrapped Safe-Wrap glass capillary blood collection tubes (CT 095 for the Abbott i-STAT system and CT 220 standard), and tonometer accessories. Products are designed for compatibility with specific installed-base analyzers including Abbott i-STAT, Accriva AVOXimeter 1000E/4000, LifeHealth IRMA TRUpoint, and Hemocue systems, and several SKUs carry CE marking for sale in the European Economic Area.

The business operates a sales-led, direct-distribution model, reaching customers via a toll-free sales line, email-based customer service and technical support, a registered-account online ordering portal, and a dedicated statistics department. Pricing is published on a 2026 USD price list and is unit-based (per pack or box of ampuls/bottles/caps/tubes), with no recurring subscription component. Revenue is generated from one-time consumable sales across hospitals, clinical laboratories, point-of-care facilities, and physician offices worldwide; international orders outside the US and Canada require prepayment by wire transfer or credit card.

A core differentiator is the PeerQC program, a free web-based inter-laboratory peer statistical service patented in 1999 as the first such service with real-time data submission and reporting, which generates a decades-long reference database across Chemistry, Coagulation, Critical Care, Hematology, and Immunoassay diagnostics and is offered at no charge to customers purchasing RNA Medical controls. Customer support is supplemented by technical services for QC results, product information, and analyzer troubleshooting, and the company conducts periodic customer satisfaction surveys. No venture funding rounds, M&A activity, leadership changes, or executive team disclosures were identified in the input data.

Name

RNA Medical

Legal name

RNA Medical

Website

https://rnamedical.com

Company type

Private

Founded year

1981

Operating status

Operating

Headcount range

51–100 employees

Short description

RNA Medical supplies assayed quality control materials, calibration verification controls, and Safe-Wrap capillary blood collection tubes to hospitals, clinical laboratories, point-of-care facilities, and physician offices worldwide, operating as a Bionostics/Bio-Techne subsidiary from its GMP facility in Devens, MA.

Ownership category

akta.pro rank

Product category

In-vitro Diagnostics Quality Control Materials

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Quality Control, Calibrators, Standards & Proficiency Testing (IVD Consumables) (HLAHAAAL)

akta.pro secondary industry

Blood Bank, Transfusion Medicine & Immunohematology (HLAHAAAH)

Keywords

• In-vitro diagnostics quality control
• Blood gas controls
• Calibration verification materials
• Capillary blood collection tubes
• Clinical laboratory supplies

Headquarters

HQ city

Devens

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Quality Control Materials Sales: RNA Medical generates revenue through the sale of quality control materials including aqueous (dye-based) and bovine blood based products for blood gas, critical blood analyte, and CO-Oximetry testing. Products include multi-level and single-level control sets sold in ampul quantities.
2. Blood Collection Tubes and Accessories: Sale of Safe-Wrap blood collection tubes, end caps, and accessories for Point-of-Care testing systems like i-STAT.
3. Calibration Verification Controls: Sale of calibration verification controls (CVC) for confirming calibration and linearity of blood gas, electrolyte, metabolite, and CO-Oximeter instrumentation.
4. PeerQC Statistical Services: Free statistical program offered to RNA Medical customers purchasing controls. Web-based peer comparison and reporting service available at no charge.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels5 records

Core offering

RNA Medical develops and supplies quality control materials, calibration verification controls, and Mylar-wrapped capillary blood collection tubes used in clinical laboratories and point-of-care settings worldwide. The product line comprises aqueous (dye-based) and bovine blood-based QC materials for blood gas, critical blood analyte, BUN, metabolite, and CO-Oximetry testing, complemented by Safe-Wrap capillary tubes and the free PeerQC inter-laboratory peer statistical service.

Product overview

RNA Medical offers a comprehensive portfolio of quality control materials, calibration verification controls, and blood collection products for the clinical laboratory and point-of-care testing markets. The product line centers on aqueous (dye-based) and bovine blood-based QC materials for blood gas, critical blood analyte, and CO-Oximetry testing, including QC 823, CC 527, and QC 253 controls at multiple levels. Calibration verification is supported through CVC 123 (for blood gas/electrolyte/metabolite) and CVC 223 (for CO-Oximeter) products with 5 levels for linearity verification. Safe-Wrap branded capillary blood collection tubes (CT 095 for i-STAT and CT 220 standard) feature Mylar-wrapped glass capillaries with heparin treatment. The portfolio also includes QC HGB for Hemocue hemoglobin analyzers and EQUILibrator tonometer accessories. All products are supported by the free PeerQC statistical services program, a web-based peer comparison platform with patented real-time reporting capabilities.

Differentiator

Problem solved

Functional benefit

Brands

• PeerQC: Statistical program for inter-laboratory peer comparison and web-based statistical analysis services for quality control.
• Safe-Wrap

Products and services

• QC 823 Blood Gas, Electrolyte, Metabolite, BUN Control Assayed aqueous quality control material for monitoring the performance of blood gas, electrolyte, metabolite, and BUN instrumentation. Available in three levels at $169 for a Multi-Level pack (10 ampuls each level). Features a 36-month shelf life with a 9-month room temperature storage option.
• CC 527 Blood Gas, Electrolyte, CO-Oximeter Control Assayed bovine blood-based quality control material for monitoring the performance of blood gas, electrolyte, and CO-Oximeter instrumentation, specifically designed for use on Accriva AVOXimeter 1000E and 4000 CO-Oximeters and the LifeHealth IRMA TRUpoint blood analysis system. Available in three levels; CE-marked.
• QC 253 Full Range CO-Oximeter Control Bovine hemoglobin-based assayed quality control material for monitoring total hemoglobin and hemoglobin fraction measurements (tHb, O2Hb, COHb, MetHb, VolO2, RHb) on CO-Oximeter instrumentation. Requires refrigeration storage with 18-month shelf life; CE-marked.
• CVC 123 Calibration Verification Controls Assayed calibration verification controls for confirming the calibration and linearity of blood gas, electrolyte, and metabolite instrumentation. Features 5 levels covering the significant range of analyzer performance with on-line statistical analysis for data calculation, reporting, and graphing.
• CVC 223 CO-Oximeter Calibration Verification Controls Assayed calibration verification controls for confirming calibration, linearity, and reportable range for tHb, O2Hb, COHb, and MetHb measurements on CO-Oximeter instrumentation.
• CT 095 Safe-Wrap Combo Blood Collection Tubes Mylar-wrapped glass capillary tubes treated with calcium-balanced lithium heparin, designed for use with the Abbott Point of Care i-STAT System (65 μL and 95 μL cartridges). The puncture-resistant Mylar film contains both the glass and the sample in the event of accidental breakage. Pack of 50 tubes with 50 dispensing plungers; CE-marked.
• CT 220 Safe-Wrap Blood Collection Tubes Heparinized glass capillary devices wrapped in puncture-resistant Mylar film for the collection of capillary blood samples for measurement of pH, blood gases, and electrolytes (excluding lithium). Holds up to 220 μL of sample; calcium-balanced lithium heparin treatment minimizes clotting risk; CE-marked.
• EC 220 End Caps End caps for Safe-Wrap Blood Collection Tubes, packaged as a package of 200. Available in the US and Canada only.
• QC HGB Hemoglobin Control Assayed quality control material of stabilized human red cells designed for Hemocue analyzers measuring total hemoglobin. Available in 3 levels (Low, Normal, High) for monitoring analyzer performance within the clinical range. Features a 24-month shelf life with flexible storage options.
• T310 Pre-Treated Syringes Pre-treated syringes for use with the EQUILibrator Tonometer, packaged as a box of 100.
• T311 Syringe Caps Syringe caps for use with the EQUILibrator Tonometer, packaged as a package of 100.
• PeerQC Statistical Services Web-based inter-laboratory peer statistical program enabling customers to review their quality control results in comparison with a peer group. Provides web-based graphing for calibration verification controls, automatic unit conversion, and peer reports. Available at no charge to RNA Medical customers purchasing controls; patented technology.

Quantifiable outcome

• 36 month shelf life for QC 823 and CC 527 products
• +3 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration4 records

Feature2 records

Partnerships

One partnership is on record.

• Bionostics, Inc.coreStrategic or Co-development PartnerRNA Medical is a trademark of Bionostics, Inc., a leading manufacturer of QC products for in-vitro diagnostics. Bionostics supplies QC materials to some of the industry's most respected diagnostics companies. RNA Medical operates within Bionostics' portfolio, leveraging shared manufacturing capabilities and statistical services expertise (through parent company) for Chemistry, Coagulation, Critical Care, Hematology, and Immunoassay diagnostics.

Scale indicators3 records

Recent moves6 records

Expansion highlights4 records

Direct peers

• Bio-Rad Laboratories: Bio-Rad's Clinical Diagnostics division is the largest independent manufacturer of third-party QC materials for blood gas, chemistry, hematology, and immunoassay. It directly competes with RNA Medical's QC 823, CC 527, and CVC product lines across hospital and reference lab customers.
• Streck: Streck supplies hematology, coagulation, and blood gas quality control materials as well as calibrators to clinical labs worldwide. Its product breadth in hematology and blood bank QC makes it a close direct competitor in the same hospital and reference lab channel.
• Quantimetrix: Quantimetrix specializes in assayed quality control materials for clinical chemistry, immunoassay, and urine chemistry. It is a direct peer in the third-party QC consumables market served by independent diagnostic manufacturers.
• Maine Molecular Quality Controls: MMQCI manufactures third-party molecular and serology QC controls and calibration verification materials for clinical labs. It is a direct peer in the independent IVD QC consumables category, though its focus is more molecular than blood gas.
• SERO (Sero AS): Sero develops and manufactures third-party QC sera and calibrators for clinical chemistry and immunochemistry. It competes with RNA Medical's QC and CVC portfolio, particularly with hospital and reference laboratory customers globally.
• Microbix Biosystems: Microbix produces quality control products for infectious disease and hematology diagnostics, including PROCEEDx and REDx controls. It overlaps with RNA Medical in IVD QC consumables and reference materials for clinical laboratories.
• Technopath Clinical Diagnostics: Technopath manufactures third-party QC materials and calibration verification controls for clinical chemistry, hematology, and immunoassay. It competes directly with RNA Medical's multi-analyte QC and CVC kits in hospital and lab markets.

Broad incumbents

• R&D Systems (Bio-Techne brand): R&D Systems is a Bio-Techne sister brand that, via Bionostics' hematology line, supplies whole blood hematology controls and calibrators to hospitals and clinical labs. It is a sibling offering within the same parent, addressing overlapping QC needs.
• Siemens Healthineers (DCA Vantage): Siemens manufactures DCA Vantage analyzers, a Point-of-Care HbA1c platform cited in RNA Medical's trademark notices. As a broad incumbent in in-vitro diagnostics, Siemens competes and complements RNA Medical in the POC QC ecosystem.

Others

• Abbott Point of Care: Abbott manufactures the i-STAT system, for which RNA Medical's CT 095 Safe-Wrap Combo tubes are designed. Abbott is both a key integration partner (its cartridge drives tube demand) and a potential competitor via its own QC offerings.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/rnamedical
• LinkedInlinkedin.com/company/rna-medical-a-division-of-bionostics-

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

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 RNA Medical