CLIAwaived

What CLIAwaived does

CLIAwaived, Inc. is a privately-held wholesale distributor founded in 2003 and headquartered in Carlsbad, California, specializing in CLIA-waived point-of-care diagnostic testing products. The company operates as a B2B e-commerce marketplace serving US healthcare providers that hold valid CLIA licenses, including physician offices, urgent care centers, clinical laboratories, and pharmacies. Customers must provide a valid CLIA license number to complete purchases, and orders are fulfilled primarily through the company's website with phone-based inside-sales support and same-day shipping on orders placed before 8 PM Eastern Time.

The product portfolio spans more than eight major categories — COVID-19 and respiratory testing (influenza, RSV, strep), infectious disease (mono, STD panels), women's health, drug and alcohol testing, and general health screening (cardiac markers, cholesterol, glucose, hemoglobin, urinalysis). Underlying technologies distributed include lateral flow immunoassays, fluorescent immunoassays (FIA), and immunochromatographic assays, many of which can be visually read or run through dedicated analyzer systems such as the BD Veritor Plus, Sofia 2, CardioChek Plus, and LeadCare II. CLIAwaived aggregates products from major manufacturers including BD, Quidel (now QuidelOrtho), Abbott/Alere, Sekisui Diagnostics (OSOM, Acucy), ACON Laboratories (Flowflex), LifeSign/PTS (Status), HemoCue, and Nano-Check, providing customers a multi-brand single-supplier relationship.

Revenue mechanics rest on per-unit and volume-tiered pricing across both consumable test kits and capital analyzer hardware, with explicit volume discounts (e.g., tiered reductions on INDICAID, OSOM, Status, BINAX, and QuickVue SKUs), promotional pricing, and a price-match guarantee. The business carries no disclosed external funding, no parent company, no M&A activity, and operates exclusively in the domestic US market with stated geographic exclusions for Alaska, Hawaii, Puerto Rico, and other outlying areas. SIC 5122 / NAICS 424210 classification confirms wholesale drug and diagnostic product distribution as the core operating model.

Name

CLIAwaived

Legal name

CLIAwaived, Inc.

Website

https://cliawaived.com

Company type

Private

Founded year

2003

Operating status

Operating

Headcount range

11–50 employees

Short description

CLIAwaived is a US wholesale distributor selling CLIA-waived point-of-care diagnostic test kits, analyzers, and consumables from major manufacturers to licensed healthcare providers, laboratories, and pharmacies through its e-commerce platform.

Ownership category

akta.pro rank

Headquarters

HQ city

Carlsbad

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, Infrastructure

Revenue model

1. Medical Diagnostic Test Products: Sale of CLIA-waived rapid diagnostic test kits including COVID-19, influenza, RSV, strep, mono, and other infectious disease tests. Products sold as one-time purchases with varying unit counts per kit.
2. Medical Supplies and Consumables: Sale of supporting medical supplies including blood collection supplies, specimen collection tools, controls, reagents, and laboratory consumables required to conduct diagnostic testing.
3. Analyzer Systems: Sale of diagnostic instrument systems such as BD Veritor Plus Analyzer, Sofia 2 Analyzer, CardioChek Plus, and other reading devices required to run specific test kits.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

CLIAwaived is a wholesale distributor of CLIA-waived point-of-care medical diagnostic products, rapid test kits, and supporting analyzer systems sourced from manufacturers such as BD, Quidel, Abbott/Alere, ACON, Sekisui, LifeSign, OraSure, and HemoCue. Products cover infectious disease (COVID-19, flu, RSV, strep, mono), drug and alcohol testing, STD and women's health, and chronic-condition screening (cardiac, cholesterol, glucose, A1c), sold exclusively to verified U.S. healthcare buyers holding valid CLIA licenses.

Product overview

CLIAwaived, Inc. is a wholesale distributor of point-of-care medical diagnostic and laboratory testing supplies. The company operates as a marketplace offering lab supplies, drug testing devices, health screening analyzers, and medical diagnostic test products. The product portfolio spans multiple categories including COVID-19 testing (antigen tests, combo tests for COVID/Flu/RSV), respiratory disease testing (influenza, RSV, strep), infectious disease testing (mono, STD panels), and general health screening (blood chemistry, cardiac markers, urinalysis). The company distributes products from multiple manufacturer brands including BD (Veritor system), Quidel (QuickVue, Sofia), Sekisui Diagnostics (OSOM), OraSure (Clearview), Abbott (BinaxNOW), and sells its own CLIAwaived branded products. Products range from CLIA-waived rapid tests that can be used at point-of-care settings to analyzer-based systems requiring dedicated readers. The business model requires customers to provide valid CLIA license numbers for purchase.

Differentiator

Problem solved

Functional benefit

Products and services

• BD Veritor PLUS SARS Promo Promotional package containing two SARS rapid antigen test kits and one BD Veritor PLUS Analyzer for detection of SARS-CoV-2 using lateral flow immunoassay technology with digital read on the BD Veritor Plus Analyzer.
• BD Veritor PLUS Triplex Promo (SARS & FLU A+B) Promotional package for rapid detection and differentiation of SARS-CoV-2, Flu A, and Flu B from a single sample in 15 minutes, including two triplex test kits and one BD Veritor PLUS Analyzer.
• BD Veritor System Triplex Test for SARS-CoV-2 & Flu A+B Lateral flow immunoassay test kit for rapid detection and differentiation between SARS-CoV-2, Flu A, and Flu B from one sample in 15 minutes. Requires BD Veritor Plus Analyzer running firmware v5.50 or higher. CLIA-waived with 86.7% sensitivity for SARS-CoV-2.
• Status COVID-19/Flu A&B Test Kit Rapid immunoassay for simultaneous direct detection and differential diagnosis of SARS-CoV-2, Influenza Type A and Type B antigens from anterior nasal and nasopharyngeal swab specimens, visually read in 15 minutes under FDA Emergency Use Authorization.
• WELLlife COVID-19 / Influenza A&B Test Kit Combo test that differentiates between SARS-CoV-2, influenza A, and influenza B antigens using an anterior nasal swab specimen, with results in 10 minutes.
• INDICAID COVID-19 Rapid Antigen Test Kit Lateral flow immunoassay for qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal swab specimens, with results in 20 minutes.
• QuickVue SARS Antigen FIA Dipstick Lateral flow immunoassay using fluorescent immunoassay technology for qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in anterior nares swab specimens. Used with Sofia 2 and Sofia analyzers for automated 15-minute results.
• Sofia SARS Antigen Test Kit Fluorescent immunoassay (FIA) using lateral flow technology for qualitative detection of nucleocapsid protein from SARS-CoV-2 with automated 15-minute results on Sofia/Sofia 2 analyzers. CLIA-waived with 96.7% PPA and 100% NPA.
• OSOM Ultra Plus Flu A&B Test Kit In vitro rapid qualitative test detecting influenza type A and type B nucleoprotein antigens from nasal or nasopharyngeal swab specimens, with pre-measured extraction buffer and 10-minute differentiated results.
• Nano-Check RSV Rapid Test Kit Rapid immunochromatographic assay for qualitative detection of RSV nucleoprotein antigen in anterior nasal swab specimens. Indicated for infants and pediatric patients aged 6 months to 6 years, and adults over 60. FDA 510(k) cleared and CLIA-waived with 15-minute results.
• ClearView RSV Rapid Test Kit Rapid immunochromatographic assay for qualitative detection of RSV fusion protein antigen in nasal wash and nasopharyngeal swab specimens. FDA-cleared and CLIA-waived with 93.8% sensitivity and 97.7% specificity, results in 15 minutes.
• Veritor RSV Test Kit Chromatographic immunoassay with instrumented read for qualitative detection of RSV fusion protein from nasopharyngeal swab. For use with BD Veritor System Reader, with 11-minute results. CLIA-waived.
• Quidel QuickVue RSV Test Kit Dipstick immunoassay for rapid qualitative detection of RSV antigen from nasopharyngeal swab or aspirate specimens, with results in 15 minutes or less at room temperature storage. FDA-cleared and CLIA-waived.
• Quidel QuickVue Influenza A/B Tests Rapid qualitative detection of influenza type A and type B antigens from nasal swab, nasopharyngeal swab, wash, or aspirate specimens. First CLIA-waived rapid influenza test with 10-minute results and 24-month shelf life.
• LifeSign Status Flu A/B Tests In vitro rapid qualitative test detecting influenza type A and type B antigens from nasal swab, nasopharyngeal swab, or aspirate/wash specimens. CLIA-waived with flip test design and pre-measured extraction reagent capsule; detects H1N1.
• Sofia RSV Test Kit Fluorescent immunoassay (FIA) for detection of RSV nucleoprotein antigen in nasopharyngeal swab and aspirate/wash specimens. Used with Sofia or Sofia 2 analyzers for qualitative diagnosis of acute RSV infections.
• Flowflex COVID-19 Antigen Home Test COVID-19 antigen home test using anterior nasal swab specimens with results in 15 minutes. Self-collection for ages 14+ and by adult for ages 2-13. Identifies 93% of positive and 100% of negative specimens.
• OSOM Ultra Strep A Tests Color immunochromatographic assay for qualitative detection of Group A Streptococcus antigen directly from throat swab specimens using Dual Label Technology, with 5-minute results. FDA-cleared and CLIA-waived.
• Status Strep A Flip Test Kit Rapid immunochromatographic assay for qualitative detection of group A streptococcal antigen from throat swab specimens using patented single-use reagent capsules, with 5-minute results and 96% sensitivity / 99% specificity. CLIA-waived.
• QuickVue In-Line Strep A Rapid strep A test using in-line extraction to detect group A streptococcal antigen from throat swab specimens with two-color results. First rapid strep A test waived under CLIA '88. FDA-cleared and CLIA-waived.
• LifeSign Status Mono Tests One-step antibody test for infectious mononucleosis using solid-phase immunoassay for qualitative detection of IM heterophile antibodies in whole blood, serum, or plasma. CLIA-waived for whole blood with results in 3-8 minutes, 99.9% sensitivity and 98.8% specificity.
• BINAX NOW RSV Test Kit Rapid immunochromatographic assay for qualitative detection of RSV fusion protein antigen in nasal wash and nasopharyngeal swab specimens. One-step 15-minute test with onboard extraction. FDA-cleared and CLIA-waived with up to 24-month shelf life.
• Acucy Influenza A&B Test Influenza A&B test on the Acucy System providing standardized digital results with Read Now and Walk Away modes for flexible workflow. CLIA-waived.
• Drug Testing Products Urine drug test cups, test cards, adulteration controls, ETG urine tests, fentanyl testing, saliva drug tests, liquid reagents, nicotine tests, and multi-panel drug testing consumables for workplace, clinical, and insurance screening.
• Alcohol Testing Products Alcohol screening products including AlcoScreen tests, BreathScan breath tubes, home alcohol tests, mobile alcohol tests, and QED A150 quantitative tests for clinical and workplace alcohol screening.
• STD Testing Products Rapid test kits for Chlamydia/Gonorrhea/Trichomonas, HCV, HIV, and Syphilis intended for clinical point-of-care use.
• Women's Health Testing Products CLIA-waived tests for bacterial vaginosis, ovulation, pregnancy, and trichomoniasis designed for clinical and pharmacy point-of-care use.
• Health Testing & Screening Products Broad screening portfolio covering blood chemistry analyzers, BNP, cancer screening, cardiac markers, CBC hematology, cholesterol monitoring, diabetes (A1c), electrolytes, fecal occult blood, glucose, hemoglobin, H. pylori, infectious diseases, lead testing, Lyme disease, mono, mycoplasma, PSA, PT/INR, respiratory diseases, thyroid, troponin, urinalysis, vitamin D, white blood cell, GLP-1 lab tests, and testosterone testing.
• Medical Supplies and Consumables Supporting medical supplies including blood collection and safety products, caps/cups/racks/tubes, chemicals and solvents, columns and guards, gloves, oximeters, and other collection supplies required to conduct diagnostic testing.
• Diagnostic Analyzer Systems Reading and analyzer instruments required to run specific diagnostic test kits, including BD Veritor Plus Analyzer, Sofia 2 and Sofia analyzers, CardioChek Plus, LeadCare II Analyzer, HemoCue Hb 801 System, HemoCue Glucose 201 System, Piccolo Xpress Chemistry Analyzer, PathFAST Analyzer, and Acucy System.

Quantifiable outcome

• Same-day shipping on orders before 8 PM Eastern Time
• +1 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Seven partnerships are on record, tiered core.

• BD (Becton, Dickinson and Company)coreTechnology or IntegrationCLIAwaived serves as a distributor for BD diagnostic products including BD Veritor Plus system, BD Veritor SARS/Flu tests, and BD Veritor RSV tests. These products are integrated into CLIAwaived's core testing portfolio.
• QuidelcoreTechnology or IntegrationCLIAwaived distributes Quidel products including Sofia SARS Antigen tests, Sofia 2 Analyzer, QuickVue influenza tests, QuickVue RSV tests, and QuickVue SARS Antigen FIA. Quidel products represent a significant portion of the flu/RSV testing catalog.
• Abbott (formerly Alere)coreTechnology or IntegrationCLIAwaived distributes Abbott/Alere products including BinaxNOW RSV tests, ClearView RSV tests, and related diagnostic products under the Alere brand.
• ACON Laboratories (Flowflex)coreTechnology or IntegrationCLIAwaived distributes Flowflex COVID-19 antigen home tests and related ACON products for at-home and point-of-care testing.
• Sekisui Diagnostics (OSOM, Acucy)coreTechnology or IntegrationCLIAwaived distributes OSOM Ultra Flu A&B tests, OSOM Ultra Strep A tests, and Acucy Influenza A&B tests from Sekisui Diagnostics.
• LifeSign (Polymer Technology Systems)coreTechnology or IntegrationCLIAwaived distributes Status brand products including Status COVID-19/Flu A&B tests, Status Flu A/B tests, Status Mono tests, and Status Strep A tests.
• HemoCuecoreTechnology or IntegrationCLIAwaived distributes HemoCue products including HemoCue Hb 801 System (hemoglobin testing) and HemoCue Glucose 201 System for point-of-care blood glucose testing.

Scale indicators1 record

Recent moves5 records

Expansion highlights5 records

Broad incumbents

• McKesson Corporation: Largest US pharmaceutical and medical-surgical distributor; competes with CLIAwaived across physician-office and laboratory diagnostic supply channels, but operates broadly across pharma, biologics and medical-surgical rather than specializing in CLIA-waived point-of-care tests.
• Cardinal Health: Major medical product distributor serving physician offices, laboratories, hospitals and ambulatory care; overlaps CLIAwaived in clinical lab supplies and POC diagnostics but as part of a much broader medical distribution portfolio.
• Henry Schein: Large medical and dental supplies distributor with a strong physician-office and ambulatory care channel; serves many of the same physician-office and urgent-care customers that CLIAwaived targets for rapid diagnostic test kits.
• Medline Industries: Largest privately held medical supply manufacturer and distributor in the US; supplies physician offices, labs and health systems with diagnostic consumables, exam supplies and equipment that directly overlap CLIAwaived's catalog.
• Avantor: Global distributor of laboratory supplies, equipment and diagnostic consumables (including via the VWR channel); competes with CLIAwaived in serving clinical laboratories needing diagnostic test kits, reagents, and lab supplies.
• Thermo Fisher Scientific (Fisher Healthcare channel): Supplies clinical and academic laboratories with diagnostic test kits, reagents, and rapid POC products through the Fisher Healthcare channel; overlaps CLIAwaived in laboratory diagnostic consumables even though it operates as a much broader scientific products distributor.

Others

• QuidelOrtho: Manufacturer of Sofia, Sofia 2, QuickVue, Triage and InflammaDry rapid diagnostic products and a current supplier to CLIAwaived; comparable because QuidelOrtho's CLIA-waived tests sit on CLIAwaived's shelves and represent a principal product category for the company.
• Becton, Dickinson and Company (BD): Manufacturer of the BD Veritor Plus system and Veritor SARS/Flu/RSV tests that anchor a large portion of CLIAwaived's analyzer-and-kit offering; relevant peer because BD could in principle bypass distributors and reach end customers directly through its own channels.
• OraSure Technologies: Manufacturer of ClearView, OraQuick and other rapid diagnostic tests (including the legacy Alere infectious disease line); a CLIAwaived supplier whose products sit in the same CLIA-waived catalog and could be vertically integrated into competing distribution.
• Sekisui Diagnostics: Manufacturer of OSOM rapid tests (Strep A, Ultra Flu A&B, Ultra Plus Flu) and Acucy analyzers distributed by CLIAwaived; included as a peer because Sekisui controls the IP underlying a meaningful share of CLIAwaived's strep/flu offering and represents a competing go-to-market.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/cliawaived
• Facebookfacebook.com/CLIAwaived
• LinkedInlinkedin.com/company/cliawaived-inc-

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 CLIAwaived