What Pro-Lab Diagnostics USA does

Pro-Lab Diagnostics USA, founded in 1986 and headquartered in Georgetown, Texas, is the US distribution and sales arm of Pro-Lab International Inc. The company manufactures and distributes in vitro diagnostic (IVD) reagents, molecular biology consumables, and laboratory equipment for clinical microbiology, molecular diagnostics, and women's health. Its core product portfolio is anchored by the Prolex™ latex agglutination line (streptococcal grouping, staphylococcal identification, E. coli O157/Non-O157 detection), the ProAmpRT™ isothermal LAMP-based arbovirus surveillance system (for WNV, Dengue, Zika, EEE, WEE, SLE, LAC, CHIKV), and the FDA 510(k)-cleared AmnioTest™ sterile amniotic fluid sampling swab with nitrazine pH indicator. Supporting offerings include the Mag Pro-32 automated nucleic acid extractor, Pro-Mag and Pure Pro-Spin RNA extraction kits, Pro-Cool ultra-low freezers, Pro-Safe biosafety cabinets and fume hoods, the Microbank cryopreservation system, and Pro-Stains microbiology staining reagents.

The company operates an ISO 13485:2016-certified manufacturing and distribution facility at Georgetown, TX (continuous certification since October 2015, NQA certificate #15775, zero non-conformances at the June 2026 surveillance audit) and maintains CE IVD, MDSAP, CAP/CLIA, and ISO 15189 compliance frameworks. Manufacturing is performed by affiliated Canadian entities in Richmond Hill, Ontario and Toronto, with US-based sales, marketing, and distribution run from Georgetown and a Round Rock, TX shipping location. Products are sold directly through the pro-lab-direct.com e-commerce platform with Net 30 terms for verified clinical institutions, and through five Tier-1 lab supply distributors — Thermo Fisher Scientific, Medline, VWR (Avantor), Cardinal Health, and McKesson. Pricing is unit-based across reagents ($43-$487 per kit) and consumables, with quote-based pricing for QC organisms, stains, equipment, and bulk volume. Primary customer segments include hospital systems, public health laboratories, academic medical centers, independent clinical labs, vector-control districts, and labor & delivery units; named end-users span Hix Farm Brewery (food/beverage QC) and government agencies (USDA, FDA, CDC, NASA referenced in technical blog content).

Name

Pro-Lab Diagnostics USA

Legal name

Pro-Lab Diagnostics USA

Website

https://pro-lab-direct.com

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

11–50 employees

Short description

Pro-Lab Diagnostics USA manufactures and distributes ISO 13485-certified IVD reagents, molecular biology consumables, and laboratory equipment to hospital systems, public health labs, academic medical centers, and independent clinical laboratories across North America.

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics (IVD) / Clinical Microbiology Reagents

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical Equipment and Supplies Manufacturing (3391), Analytical Laboratory Instrument Manufacturing (334516)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Laboratory Analytical Instruments (3826)

akta.pro primary industry

Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes) (HLAGAIAI)

Keywords

• In vitro diagnostics
• Clinical microbiology reagents
• Latex agglutination tests
• Molecular diagnostic kits
• Laboratory equipment supplies

Headquarters

HQ city

Round Rock

HQ country

United States

HQ region

North America

Offices5 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. IVD Reagent Sales: Sale of CE IVD-marked clinical diagnostic reagents including microbiology kits (Prolex streptococcal/staphylococcal grouping, E. coli latex kits), biochemical reagents (TestOxidase, coagulase plasma), antisera, stains, and specialty consumables. Direct manufacturer pricing with no distributor markup.
2. Molecular Biology Consumables: Sale of molecular biology products including RNA extraction kits (Pro-Mag, Pure Pro-Spin), LAMP detection kits (ProAmpRT), PCR plates, pipette tips, nuclease-free water, and decontamination solutions. RUO and IVD products.
3. Laboratory Equipment: Sale of laboratory equipment including ultra-low freezers (Pro-Cool -86°C), biosafety cabinets (Pro-Safe), chemical fume hoods, and sterilization equipment (Bacti-cinerator). ISO 13485 certified manufacturing.
4. Net 30 Institutional Accounts: Net 30 payment terms for verified clinical institutions and universities. Standard payment terms for approved credit accounts; new customers pay in advance via ACH, wire, or credit card.

Pricing tiers

Go-to-market motion2 records

Distribution channels6 records

Marketing channels5 records

Core offering

Pro-Lab Diagnostics USA manufactures and distributes IVD-certified clinical microbiology reagents (latex agglutination kits, biochemical reagents, stains, antisera, QC organisms), molecular biology products (LAMP-based arbovirus surveillance kits, RNA extraction kits, PCR consumables), and laboratory equipment (biosafety cabinets, ultra-low freezers, fume hoods). The company serves hospital systems, public health laboratories, academic medical centers, independent clinical labs, and vector-control programs through direct e-commerce sales and major distributor channels (Thermo Fisher, Medline, VWR, Cardinal Health, McKesson) at direct manufacturer pricing without distributor markup.

Product overview

Pro-Lab Direct is the U.S. distribution arm of Pro-Lab Diagnostics USA, operating as a direct-to-laboratory manufacturer and distributor of clinical IVD reagents, molecular biology consumables, and laboratory equipment. The portfolio spans three broad categories: (1) Clinical Microbiology — the Prolex™ latex agglutination product line for streptococcal grouping (PL.030), staphylococcal identification (PL.080B/PL.1080/PL.1081), E. coli O157 and Non-O157 typing (PL.070B/PL.1070), enteric antisera, biochemical reagents (TestOxidase™ PL.390, Kovacs' Reagent PL.375, Spot Indole PL.391-10), specimen processing (Mucolyse™ PL.701), plasma reagents (Rabbit Coagulase PL.850), QC organisms (Pro-Cult®), culture preservation (Microbank®), microbiology stains (Pro-Stains™), and calibrated consumables (Pro-Loops™ PL.100); (2) Women's Health — AmnioTest™ (PL.901) FDA 510(k)-cleared sterile amniotic fluid sampling swab with nitrazine pH indicator, plus color reference cards (PL.902) and QC buffer solutions (PL.910–915); and (3) Molecular Biology / Arbovirus Surveillance — the ProAmpRT™ system for vector-control surveillance, comprising the Mosquito Collection & Homogenization Kit (PLM-2008), Pure Pro-Spin™ RNA Extraction Kit (PLM-2004), Pro-Mag™ RNA Extraction Kit (PLM-2000), Mag Pro-32 automated extraction instrument (PLM-NPA-32), Pro-AmpRT™ WNV Isothermal Kit (PLM-1008), and distributed Optigene Genie® LAMP instruments (Genie II/III/HT), plus molecular consumables (Pro-Tips™ pipette tips, 96-Well PCR Plates, Pro-Wipe™ Molecular Solution, DNase/RNase Free Water). Laboratory equipment includes Pro-Cool™ ultra-low freezers, Pro-Safe™ biosafety cabinets and fume hoods, and Pro-Sterilizer™ Bacti-cinerators. Lab supplies include TransVelope™ biohazard transport bags, Nitrile Exam Gloves (PLG100), ProRax™ petri dish racks, and DBP-Free Immersion Oil (PL.396). The company holds ISO 13485:2016 certification (NQA/ANAB, Cert #15775, continuous since October 2015) and operates under CE IVD, CAP/CLIA, and MDSAP compliance frameworks.

Differentiator

Problem solved

Functional benefit

Brands

• Prolex: IVD brand for streptococcal grouping, staphylococcal typing, and E. coli latex identification reagents
• ProAmpRT
• Microbank
• AmnioTest
• Pro-Cool
• Pro-Safe
• Pro-Stains
• Optigene Genie
• Pro-Mag
• TransVelope
• McFarland Standards
• Pro-Sterilizer
• Pro-Loops
• Mag Pro-32

Products and services

• Prolex™ Streptococcal Grouping Kit (PL.030) Rapid latex agglutination test for identification of streptococcal Groups A, B, C, D, F & G with 99% sensitivity and 100% specificity confirmed in independent peer-reviewed 302-isolate study. CE IVD marked, 60-test kit format for clinical microbiology laboratories.
• Prolex™ Staphylococcal Identification Kit (PL.080B / PL.1080 / PL.1081) Latex agglutination kits for staphylococcal identification and differentiation. Available in 100-test and 300-test formats. Used by clinical microbiology laboratories for rapid identification of Staphylococcus aureus and other species.
• Prolex™ E. coli O157 Latex Kit (PL.070B / PL.071B) Latex agglutination kit for identification of E. coli O157:H7 serotype in clinical and food microbiology workflows. 50-test format, CE IVD marked for clinical microbiology laboratories.
• Prolex™ E. coli Non-O157 Latex Kit (PL.1070) Latex agglutination kit for identification of non-O157 Shiga toxin-producing E. coli (STEC) serotypes in clinical microbiology laboratories. 50-test format.
• TestOxidase™ Reagent (PL.390) Ready-to-use cytochrome oxidase reagent for rapid oxidase spot testing in bacterial identification. 30-second read time, 9-month shelf life, 15 mL vial format for clinical microbiology labs.
• Rabbit Coagulase Plasma EDTA (PL.850) EDTA-formulated rabbit coagulase plasma for differentiation of Staphylococcus aureus from coagulase-negative staphylococci. Available in 10 mL and 30 mL formats for clinical microbiology laboratories.
• Microbank® Cryovial Storage System (PL.170) Bead-based cryopreservation system for long-term storage of bacterial and fungal isolates. 80 cryovials per kit, with 35+ years of peer-reviewed evidence supporting 10-year viability documentation. The original and most cited bead storage system in clinical microbiology.
• Pro-Stains™ Microbiology Stains Complete range of microbiology staining reagents including Gram stain, Ziehl-Neelsen (ZN) Acid-Fast stain, and Auramine stain. Over 130 SKUs covering clinical microbiology staining workflows for routine and specialized applications.

Quantifiable outcome

• Prolex Strep Kit: 99% sensitivity, 100% specificity confirmed in 302-isolate independent study (PMID 14560788)
• +3 more outcomes

Named customers8 records

Segments8 records

Ideal customer profiles6 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Seven partnerships are on record, tiered core.

• Thermo Fisher ScientificcoreChannel Partner/ Reseller/ DistributorMajor global lab supply distributor carrying Pro-Lab products including Microbank cryovial storage system. One of five major distributor partners enabling broad market reach.
• MedlinecoreChannel Partner/ Reseller/ DistributorMajor medical supply distributor partner. Carries Pro-Lab diagnostic products through Medline's healthcare distribution network.
• VWR (Avantor)coreChannel Partner/ Reseller/ DistributorLab and critical equipment distributor. VWR carries Pro-Lab products including Microbank and other IVD reagents.
• Cardinal HealthcoreChannel Partner/ Reseller/ DistributorHealthcare distributor partner. Distributes Pro-Lab diagnostic products to healthcare facilities.
• McKessoncoreChannel Partner/ Reseller/ DistributorHealthcare supply chain partner. Carries Pro-Lab diagnostic products through McKesson's pharmaceutical and medical supply distribution.
• OptigenecoreTechnology or IntegrationUK-based manufacturer of Genie isothermal LAMP detection instruments (Genie II, III, HT). Pro-Lab distributes Optigene instruments and develops compatible ProAmpRT LAMP detection kits. Integrated workflow: Pro-Lab extraction kits → Optigene Genie detection.
• NQA (National Quality Assurance, USA)coreOthersANAB-accredited certification body (ISO/IEC 17021-1) that conducts ISO 13485 audits and issues certification. Certificate #15775 issued to Pro-Lab Diagnostics USA. Surveillance audit June 2026 with zero non-conformances.

Scale indicators5 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Hardy Diagnostics: Hardy Diagnostics is a US-based manufacturer and direct distributor of clinical microbiology reagents, culture media, and lab consumables — a near-direct peer in business model, customer base (hospital and clinical labs), and product mix including microbiology stains, biochemical reagents, and quality controls.
• Bio-Rad Laboratories: Bio-Rad is a major manufacturer of clinical microbiology reagents and IVD products, including latex agglutination tests for streptococcal grouping and staphylococcal identification — directly competing with Pro-Lab's Prolex line. It also sells molecular diagnostics consumables and life science research reagents, overlapping with Pro-Lab's molecular biology portfolio.

Broad incumbents

• Remel (Thermo Fisher Scientific): Remel is Thermo Fisher's clinical microbiology brand offering latex agglutination tests, biochemical reagents, and microbiology stains that directly compete with Pro-Lab's Prolex and Pro-Stains lines. Operates as part of a much larger life sciences conglomerate with significantly broader portfolio and R&D scale.
• Qiagen: Qiagen is a global leader in nucleic acid extraction (compare to Pro-Mag and Pure Pro-Spin) and molecular diagnostics, including arbovirus and infectious disease detection assays that compete with Pro-Lab's ProAmpRT LAMP workflow and Mag Pro-32 instrument.
• VWR (Avantor): VWR/Avantor is a major global lab supply distributor that both resells Pro-Lab products and offers competing private-label and OEM microbiology reagents, molecular biology consumables, and lab equipment. Represents both an indirect competitor and channel partner.
• Thermo Fisher Scientific: Beyond being a Pro-Lab distribution partner, Thermo Fisher is a broad incumbent in life sciences and diagnostics with its own branded microbiology reagents (Remel), molecular biology consumables, and IVD instrumentation. Represents both an indirect competitor and a channel partner.
• Meridian Bioscience (now Revvity): Meridian Bioscience (acquired by Revvity/Euroimmun) manufactures IVD reagents and molecular diagnostic kits for infectious disease detection, including sample preparation and amplification products comparable to Pro-Lab's Pure Pro-Spin and ProAmpRT product lines.
• QuidelOrtho: QuidelOrtho manufactures IVD rapid diagnostic tests, microbiology reagents, and molecular diagnostics products, overlapping with Pro-Lab's Prolex agglutination kits and AmnioTest PROM screening products across hospital and clinical lab customer bases.

Emerging players

• HiMedia Laboratories: HiMedia is an India-based manufacturer of microbiology culture media, biochemical reagents, and lab consumables with an expanding international footprint in clinical microbiology — comparable product breadth to Pro-Lab at a competing price point in emerging markets.
• OptiGene: OptiGene is a UK-based manufacturer of isothermal LAMP instruments (Genie II, III, HT) whose products Pro-Lab distributes in the US. Operates as a technology partner and adjacent emerging player in the LAMP-based molecular diagnostics space rather than a direct competitor.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• Facebookfacebook.com/labtest.bio
• LinkedInlinkedin.com/company/pldusa

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries2 records

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 Pro-Lab Diagnostics USA