Precision BioLogic
Precision BioLogic develops and manufactures frozen diagnostic controls, reagents, and chromogenic assays for clinical hemostasis and coagulation laboratories in North America, Europe, Asia-Pacific, and Oceania. Owned by Procuritas Capital Investors VII since February 2024.
- Company typePrivate
- Founded1992
- HeadquartersDartmouth, Canada
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What Precision BioLogic does
Precision BioLogic Incorporated is a Nova Scotia, Canada-based developer and manufacturer of frozen diagnostic products used by clinical hemostasis and coagulation laboratories. Founded in 1992 and headquartered in Dartmouth, the company sells its CRYOcheck line of controls, specialty plasmas, factor deficient plasmas, reagents, and diagnostic kits to clinical laboratories performing routine coagulation testing, hemophilia management, lupus anticoagulant detection, and thrombophilia screening. Products are sold in frozen format to eliminate reconstitution errors, with extended shelf life of two to three years, color-coded compact packaging, and platform-independent performance on automated coagulation analyzers. The portfolio includes the first FDA-cleared chromogenic Factor VIII assay for automated instruments (launched 2020) and an updated bovine formulation cleared in 2025 for monitoring emerging FVIIIa mimetic bispecific antibody therapies.
The company operates a hybrid commercial model: direct sales and customer support within North America combined with a network of specialized distributors covering 14+ European countries plus Australia, New Zealand, Korea, Japan, and Taiwan. The company holds FDA 510(k) clearances, ISO 13485:2016 certification, MDSAP certification, and IVDR QMS certification (obtained June 2023), collectively enabling access to the US, EU, Japan, Canada, and Australian markets. Precision BioLogic has expanded through two acquisitions: Affinity Biologicals (November 2018), adding coagulation-related antibodies and ELISA kits for research and diagnostics, and George King Bio-Medical, Inc. (October 16, 2025), adding specialty fresh frozen human plasma products with ties to the bleeding disorders community. The company was acquired by private equity firm Procuritas Capital Investors VII in February 2024. Pricing is quote-based per unit/vial, with no public price list; revenue is not publicly disclosed.
Precision BioLogic firmographics
Firmographics- Name
- Precision BioLogic
- Legal name
- Precision BioLogic Incorporated
- Website
- https://precisionbiologic.com
- Company type
- Private
- Founded year
- 1992
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Precision BioLogic develops and manufactures frozen diagnostic controls, reagents, and chromogenic assays for clinical hemostasis and coagulation laboratories in North America, Europe, Asia-Pacific, and Oceania. Owned by Procuritas Capital Investors VII since February 2024.
- Ownership category
- akta.pro rank
Precision BioLogic industry classification
Industry- Product category
- Hemostasis Diagnostics
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835)
- akta.pro primary industry
- Hematology & Coagulation Diagnostics (HLAHAAAB)
- akta.pro secondary industry
- Plasma-Derived Therapy Cold Chain & Specialty Logistics (HLAIAHAL)
Keywords
Where Precision BioLogic is headquartered
LocationHeadquarters
- HQ city
- Dartmouth
- HQ country
- Canada
- HQ region
- North America
Offices1 record
Markets served
Precision BioLogic business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Operations, Supply Chain, Personnel, Technology or R&D, Marketing or Sales, Infrastructure
Revenue model
- Diagnostic Products Sales: Precision BioLogic develops, manufactures, and markets frozen diagnostic products for hemostasis labs. Revenue comes from sale of controls, specialty plasmas, reagents, and diagnostic kits to clinical laboratories.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Unit Pricing | Pay-as-you-go | Quote-based pricing for all products |
Go-to-market motion2 records
Distribution channels2 records
Marketing channels7 records
Precision BioLogic product offering
Product offeringCore offering
Precision BioLogic develops, manufactures, and markets frozen diagnostic products under the CRYOcheck brand for clinical hemostasis laboratories. The portfolio includes controls, specialty plasmas, factor deficient plasmas, reagents, and diagnostic kits used by clinical laboratories to perform coagulation testing for the diagnosis and monitoring of blood coagulation disorders such as hemophilia, lupus anticoagulant, thrombophilia, and heparin therapy. Products are sold frozen, eliminating reconstitution errors and providing extended shelf life of two to three years.
Product overview
Precision BioLogic is a developer and manufacturer of frozen hemostasis diagnostic products under the CRYO*check* brand. The company's product portfolio comprises four main categories: Controls & Specialty Plasmas (including Abnormal Controls, Reference Plasmas, Lupus Controls, Heparin Control, and Pooled Normal Plasma); Factor Deficient Plasmas (Factor II, V, VII, VIII, VIII with VWF, IX, X, XI, XII, and Prekallikrein); Diagnostic Kits (Chromogenic Factor VIII and IX assays, Clot C, Factor VIII Inhibitor Kit, Hex LA); and Reagents (LA Check, LA Sure, Platelet Lysate). All products are designed for use with automated coagulation analyzers in clinical hemostasis laboratories. The company operates an online ordering system and customer portal for lot-specific documentation. Precision BioLogic has expanded through two strategic acquisitions: Affinity Biologicals (2018) for coagulation antibodies and ELISA kits, and George King Bio-Medical (2025) for specialty hemostasis products.
Differentiator
Problem solved
Functional benefit
Brands
- CRYO*check*: The company's line of frozen hemostasis diagnostic products including controls, calibrators, reagents, and diagnostic kits for coagulation testing.
- PBInsider
- Fritsma Factor
Quantifiable outcome
- Products stable for at least two years from date of manufacture, many for three years
- +2 more outcomes
Companies that use Precision BioLogic
Customer profileNamed customers1 record
Segments3 records
Ideal customer profiles2 records
Precision BioLogic technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature7 records
Precision BioLogic partnerships and signals
Strategic signalPartnerships
Ten partnerships are on record, tiered core.
- George King Bio-MedicalcoreAcquired George King Bio-Medical, Inc. on October 16, 2025. George King Bio-Medical is a provider of hemostasis diagnostic products with close ties to the bleeding disorders community. Founded in 1973 by George J. King, the company offers quality fresh frozen human plasmas for clinical laboratories.
- Affinity BiologicalscoreAcquired Affinity Biologicals in November 2018. Affinity Biologicals is a primary manufacturer of products used worldwide in thrombosis and hemostasis research and diagnostics, offering an extensive line of coagulation-related antibodies and other products and services.
- Alpha LaboratoriescoreUK distributor covering England, Scotland, and Wales. Located at 40 Parham Drive, Eastleigh, Hampshire SO50 4NU, United Kingdom.
- CoaChrom DiagnosticacoreEuropean distributor covering Austria, Denmark, Finland, Germany, Norway, and Sweden. Located at Hauptstraße 5, 2344 Maria Enzersdorf, Austria.
- CryopepcoreEuropean distributor covering Belgium, France, Luxembourg, Netherlands, and Spain. Located at 83 rue Yves Montand – Parc 2000, 34080 Montpellier, France.
- ELITech GroupcoreDistributor covering Australia and New Zealand. ELITech Australia at 65 Mills Road, Braeside, VIC, 3195, Australia.
- Tokyo Future Style, Inc.coreDistributor covering Japan and Taiwan. Japan office at TCI A-13, 1-6, Sengen 2-Chome, Tsukuba City, Ibaraki, Japan 305-0047.
- Endotell AGcoreSwiss distributor. Located at Gewerbestrasse 25, 4123 Allschwil, Switzerland.
- FannincoreIrish distributor covering Republic of Ireland and Northern Ireland. Located at Fannin House, South County Business Park, Leopardstown, Dublin 18.
- MoreBio Inc.coreKorean distributor. Located at #F810, Testa Tower, 25, Misagangbyeonseo-ro, Hanam-si, Gyeonggi-do, Republic of Korea, 12918.
Scale indicators2 records
Recent moves6 records
Expansion highlights5 records
Precision BioLogic competitors and assessment
Company assessmentDirect peers
- Diagnostica Stago: French-headquartered global specialist in hemostasis and coagulation diagnostics, manufacturing analyzers and a broad portfolio of reagents, controls, and calibrators that directly overlap Precision BioLogic's CRYO*check* product lines across PT, APTT, factor assays, and lupus anticoagulant testing.
- Sysmex Corporation: Global leader in hematology and hemostasis diagnostics offering automated coagulation analyzers and reagent systems; competes directly with Precision BioLogic in factor assays, lupus anticoagulant testing, and routine coagulation controls.
- Werfen (Instrumentation Laboratory): Through its Instrumentation Laboratory business, Werfen offers ACL series hemostasis analyzers and a broad reagent menu in coagulation, factor deficiency testing, and lupus anticoagulant detection that directly competes with Precision BioLogic's specialty plasmas and factor deficient plasma reagents.
- Helena Laboratories: US-based specialty manufacturer of clinical electrophoresis, hemostasis, and coagulation products including factor deficient plasmas, lupus anticoagulant reagents, and quality controls — closely comparable to Precision BioLogic's reagent and specialty plasma portfolio.
- Bio/Data Corporation: Specialty manufacturer of platelet aggregation reagents, coagulation controls, and factor deficient plasmas used in hospital and reference coagulation laboratories — a smaller, comparable specialty IVD peer in the hemostasis reagent niche.
- Sekisui Diagnostics: Diagnostics manufacturer with coagulation and hemostasis reagent offerings, including specialty plasmas, calibrators, and controls used in clinical labs — competing in the same end-user workflow as Precision BioLogic's CRYO*check* reagents.
Broad incumbents
- Siemens Healthineers: Diversified IVD major offering hemostasis analyzers and reagents within its Atellica/BCA portfolio alongside broader chemistry, immunoassay, and hematology lines — a broader incumbent whose reagent menu overlaps with Precision BioLogic at hospital and reference-lab customers.
- Roche Diagnostics: Global IVD leader providing coagulation reagents on its cobas t series analyzers, with deep contracts at large hospital networks. While broader than Precision BioLogic, its coagulation offerings address the same clinical end users.
- Abbott: Diversified diagnostics and medical device company with hemostasis reagents on its Alinity ci-series analyzers, serving many of the same hospital and reference-lab customers as Precision BioLogic with a broader reagent and instrument portfolio.
Emerging players
- HemoSonics: Emerging specialized hemostasis diagnostics company focused on viscoelastic testing (Quantra system) for point-of-care and specialty lab use; an emerging player in hemostasis diagnostics adjacent to Precision BioLogic's specialty assay positioning.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
Precision BioLogic social profiles
Digital presencePrecision BioLogic compliance and trust
Trust signalCompliance5 records
Precision BioLogic financial estimates
Financial estimateRevenue estimate
Valuation estimate
Precision BioLogic leadership team
Management profileNumber of profiles
Profiles3 records
Precision BioLogic subsidiaries and ownership
Company hierarchySubsidiaries2 records
Precision BioLogic funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Precision BioLogic M&A and investment
M&A and investmentM&A2 records
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Precision BioLogic
What does Precision BioLogic do?
Precision BioLogic develops, manufactures, and markets frozen diagnostic products under the CRYOcheck brand for clinical hemostasis laboratories. The portfolio includes controls, specialty plasmas, factor deficient plasmas, reagents, and diagnostic kits used by clinical laboratories to perform coagulation testing for the diagnosis and monitoring of blood coagulation disorders such as hemophilia, lupus anticoagulant, thrombophilia, and heparin therapy. Products are sold frozen, eliminating reconstitution errors and providing extended shelf life of two to three years.
Is Precision BioLogic a public or private company?
Precision BioLogic is a private company. It is classified as private equity controlled and is currently operating.
When was Precision BioLogic founded?
Precision BioLogic was founded in 1992. It employs 11 to 50 people.
Where is Precision BioLogic based?
Precision BioLogic is headquartered in Dartmouth, Canada, in the North America region.
How does Precision BioLogic make money?
One revenue line is on record: diagnostic Products Sales.
Who are Precision BioLogic's main competitors?
Direct peers on record are Diagnostica Stago, Sysmex Corporation, Werfen (Instrumentation Laboratory), Helena Laboratories, Bio/Data Corporation and Sekisui Diagnostics. Broad incumbents are Siemens Healthineers, Roche Diagnostics and Abbott. HemoSonics is listed as an emerging player.
Does Precision BioLogic have an API?
No public API is recorded for Precision BioLogic.
What industry is Precision BioLogic in?
Precision BioLogic's product category is Hemostasis Diagnostics. Its primary akta.pro industry code is HLAHAAAB, Hematology & Coagulation Diagnostics, with a secondary code of HLAIAHAL, Plasma-Derived Therapy Cold Chain & Specialty Logistics. Its NAICS code is 325413 and its SIC code is 2835.