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Erba Diagnostics

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Erba Diagnostics
Company typeenum
Private
Founded yearint
2001
Descriptiontext

Erba Diagnostics is a US-based in-vitro diagnostics manufacturer headquartered in Miami, Florida, founded in 2001. The company specializes in the manufacturing and marketing of proprietary diagnostic reagents, test kits, and instrumentation, serving the clinical diagnostics market through a product portfolio spanning consumables (reagents and test kits) and capital equipment (analyzers/instruments). With 101-250 employees and operations spanning more than two decades, Erba Diagnostics operates as a privately held for-profit entity in the regulated medical diagnostics sector, where its product set targets clinical laboratories and healthcare providers requiring reliable assay and instrument solutions.

The company competes in the global IVD market, which requires regulatory clearances (e.g., FDA 510(k) or PMA, CE-IVD) that function as barriers to entry. Erba's combined offering of proprietary reagents plus instrumentation creates a razor-and-blade commercial model in which instrument placements generate recurring reagent consumable revenue, though the available data does not specify pricing structure, distribution channels, or geographic footprint. The single observable capital event is a $4.225 million funding round closed on April 30, 2020, with investors and lead investor unspecified in available sources.

Available information is materially thin. No customer logos, named distribution partners, leadership team composition, product roadmap, geographic operating footprint, or financial performance metrics are disclosed in the available data. The company's website (erbadiagnostics.com) is the primary observable commercial surface. Consequently, a number of investment-relevant dimensions — including segment mix, channel strategy, installed base, regulatory footprint by jurisdiction, and revenue concentration — cannot be assessed from the provided source material.

Short descriptiontext

Erba Diagnostics is a Miami-based, privately held in-vitro diagnostics manufacturer founded in 2001 that produces proprietary diagnostic reagents, test kits, and instrumentation for clinical laboratories and healthcare providers, with a headcount of 101-250 employees.

Ownership categoryenum
Headcount rangeband
101–250
akta.pro rankint
HeadquartersMiami, United States
HQ citystring
Miami
HQ countrystring
United States
HQ regionstring
North America
Markets served

Serves global market

Keyword5 values
in-vitro diagnostics, diagnostic reagents, clinical test kits, laboratory instrumentation, clinical chemistry analyzers
Industry1 code
1IVD Reagents, Assay Kits & Consumables (Non-instrument)
CodeHLAHAAAMPrimaryYes
NAICS code2 codes
  • In-Vitro Diagnostic Substance Manufacturing325413
  • Analytical Laboratory Instrument Manufacturing334516
SIC code2 codes
  • In Vitro & In Vivo Diagnostic Substances2835
  • Laboratory Analytical Instruments3826
Product category
In-Vitro Diagnostics
No data
Cost components6 values
Supply Chain, Operations, Personnel, Technology or R&D, Marketing or Sales, Infrastructure
GTM typeB2B
B2B
Offering typeHardware or Manufacturing
Hardware or Manufacturing
Core offering1 text field

ERBA Diagnostics manufactures and markets proprietary diagnostic reagents, test kits, and instrumentation used by clinical laboratories. Its offering combines consumable diagnostic chemistries with the analytical instruments that run them, supporting routine in-vitro diagnostic testing in hospital, reference, and clinical laboratory settings.

Differentiator
Functional benefit
Problem solved
Product and service3 records
1Diagnostic Reagents
CategoryDiagnostic reagents and consumables
Description

Proprietary chemical and biological reagent formulations produced by Erba Diagnostics for performing in-vitro diagnostic tests. Sold to hospital, reference, and clinical laboratories for routine and specialized diagnostic testing.

2Diagnostic Test Kits
CategoryDiagnostic test kits
Description

Proprietary packaged test kits built around Erba's reagent formulations, designed for use in clinical laboratory diagnostic workflows. Sold to clinical laboratories and diagnostic centers.

3Diagnostic Instrumentation
CategoryLaboratory instrumentation
Description

Analytical instruments manufactured by Erba Diagnostics that run the company's diagnostic reagents and test kits. Sold to hospital, reference, and clinical laboratories performing in-vitro diagnostic testing.

Recent move1 record

Each record includes

Date, Type, Title, Description, Source

Expansion highlight1 record

Each record includes

Type, Description

Peers10 records
TypeDirect peer
Description

Mid-to-large diversified life science and clinical diagnostics manufacturer producing IVD reagents, test kits, and clinical instrumentation. Closely comparable product mix and customer base (hospital and reference labs).

TypeDirect peer
Description

IVD specialist focused on immunoassays, molecular diagnostics reagents, and rapid diagnostic kits. Direct overlap in proprietary diagnostic reagent and kit manufacturing serving clinical laboratories.

TypeDirect peer
Description

Specialty IVD company producing proprietary reagent kits and dedicated immunoassay instrumentation. Comparable reagent-instrument integration model and focus on specialty diagnostics.

TypeDirect peer
Description

Diagnostics segment manufacturer of molecular and immunoassay reagents, kits, and instruments (e.g., Panther system). Comparable proprietary reagent-and-instrument stack for clinical labs.

TypeEmerging player
Description

China-based IVD and patient monitoring manufacturer expanding globally with reagent kits and clinical chemistry / hematology analyzers. Comparable reagent-instrument portfolio at a lower price point targeting mid-tier labs.

TypeBroad incumbent
Description

Global IVD market leader offering the broadest reagent and instrument portfolio (cobas, Elecsys). Sets competitive benchmarks on assay menu, instrument throughput, and pricing.

TypeBroad incumbent
Description

Major IVD incumbent with Alinity and ARCHITECT reagent-instrument platforms spanning immunoassay, clinical chemistry, and molecular diagnostics. Dominant share of US hospital lab contracts.

TypeBroad incumbent
Description

Diversified diagnostics manufacturer offering Atellica and ADVIA Centaur reagent/instrument systems. Major competitor in mid-to-large hospital and reference lab channels.

TypeBroad incumbent
Description

Clinical chemistry, immunoassay, and hematology reagent-and-instrument vendor within Danaher's diagnostics platform. Direct overlap with ERBA's reagents + instrumentation stack.

TypeEmerging player
Description

Hematology and specialty IVD player with proprietary reagent menus and analyzers. Comparable reagent-instrument integration model, especially in clinical lab segments outside the largest US hospitals.

Market position
Strengths4 records

Each record includes

Headline, Details, Source

Weaknesses4 records

Each record includes

Headline, Details, Source

Competitive moat3 records

Each record includes

Type, Details

Key risks4 records

Each record includes

Headline, Details, Source

Key highlights4 records

Each record includes

Headline, Details, Source

Customer concentration

Classification, Details

Ideal customer profile1 record

Each record includes

Profile, Firmographic size, Sales motion, Sales cycle length, Buying structure, Purchase trigger, Buyer persona, Geography, Industry vertical, Primary use case, Description, Pain points, Evidence proof points, Target buyer

Technology focused
Yes
API detail
Has APIbool
No

Docs URL, Description

AI maturity
App detail

Has app

Core technology
Revenue estimate
Valuation estimate
Number of profiles
No data
No data
Funding overview

Funding stage, Last funding date, Total funding USD

Funding rounds1 record

Each record includes

Round, Amount USD, Date, Pre money valuation, Total investors, Investors, News

Investors

Each record includes

Name, Type, Date of entry, Rounds participated, Website

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Each record includes

Name, Acquisition type, Announced date, Completed date, Status, Website, News

Investment

Each record includes

Name, Round, Announced date, Lead investor, Website, News

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Erba Diagnostics

In-Vitro Diagnosticserbadiagnostics.com

Erba Diagnostics is a Miami-based, privately held in-vitro diagnostics manufacturer founded in 2001 that produces proprietary diagnostic reagents, test kits, and instrumentation for clinical laboratories and healthcare providers, with a headcount of 101-250 employees.

What Erba Diagnostics does

Erba Diagnostics is a US-based in-vitro diagnostics manufacturer headquartered in Miami, Florida, founded in 2001. The company specializes in the manufacturing and marketing of proprietary diagnostic reagents, test kits, and instrumentation, serving the clinical diagnostics market through a product portfolio spanning consumables (reagents and test kits) and capital equipment (analyzers/instruments). With 101-250 employees and operations spanning more than two decades, Erba Diagnostics operates as a privately held for-profit entity in the regulated medical diagnostics sector, where its product set targets clinical laboratories and healthcare providers requiring reliable assay and instrument solutions.

The company competes in the global IVD market, which requires regulatory clearances (e.g., FDA 510(k) or PMA, CE-IVD) that function as barriers to entry. Erba's combined offering of proprietary reagents plus instrumentation creates a razor-and-blade commercial model in which instrument placements generate recurring reagent consumable revenue, though the available data does not specify pricing structure, distribution channels, or geographic footprint. The single observable capital event is a $4.225 million funding round closed on April 30, 2020, with investors and lead investor unspecified in available sources.

Available information is materially thin. No customer logos, named distribution partners, leadership team composition, product roadmap, geographic operating footprint, or financial performance metrics are disclosed in the available data. The company's website (erbadiagnostics.com) is the primary observable commercial surface. Consequently, a number of investment-relevant dimensions — including segment mix, channel strategy, installed base, regulatory footprint by jurisdiction, and revenue concentration — cannot be assessed from the provided source material.

Erba Diagnostics firmographics

Firmographics
Name
Erba Diagnostics
Website
https://erbadiagnostics.com
Company type
Private
Founded year
2001
Headcount range
101–250 employees
Short description
Erba Diagnostics is a Miami-based, privately held in-vitro diagnostics manufacturer founded in 2001 that produces proprietary diagnostic reagents, test kits, and instrumentation for clinical laboratories and healthcare providers, with a headcount of 101-250 employees.
Ownership category
akta.pro rank

Erba Diagnostics industry classification

Industry
Product category
In-Vitro Diagnostics
NAICS
In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516)
SIC
In Vitro & In Vivo Diagnostic Substances (2835), Laboratory Analytical Instruments (3826)
akta.pro primary industry
IVD Reagents, Assay Kits & Consumables (Non-instrument) (HLAHAAAM)

Keywords

  • In-vitro diagnostics
  • Diagnostic reagents
  • Clinical test kits
  • Laboratory instrumentation
  • Clinical chemistry analyzers

Where Erba Diagnostics is headquartered

Location

Headquarters

HQ city
Miami
HQ country
United States
HQ region
North America

Markets served

Erba Diagnostics business model

Business model
GTM type
B2B
Offering type
Hardware or Manufacturing
Cost components
Supply Chain, Operations, Personnel, Technology or R&D, Marketing or Sales, Infrastructure

Erba Diagnostics product offering

Product offering

Core offering

ERBA Diagnostics manufactures and markets proprietary diagnostic reagents, test kits, and instrumentation used by clinical laboratories. Its offering combines consumable diagnostic chemistries with the analytical instruments that run them, supporting routine in-vitro diagnostic testing in hospital, reference, and clinical laboratory settings.

Differentiator

Problem solved

Functional benefit

Products and services

  • Diagnostic Reagents Proprietary chemical and biological reagent formulations produced by Erba Diagnostics for performing in-vitro diagnostic tests. Sold to hospital, reference, and clinical laboratories for routine and specialized diagnostic testing.
  • Diagnostic Test Kits Proprietary packaged test kits built around Erba's reagent formulations, designed for use in clinical laboratory diagnostic workflows. Sold to clinical laboratories and diagnostic centers.
  • Diagnostic Instrumentation Analytical instruments manufactured by Erba Diagnostics that run the company's diagnostic reagents and test kits. Sold to hospital, reference, and clinical laboratories performing in-vitro diagnostic testing.

Companies that use Erba Diagnostics

Customer profile

Ideal customer profiles1 record

Erba Diagnostics technology and API

Technology

Technology focussed Yes

API detail

Has API
No
API docs
API detail

Core technology

AI maturity

App detail

Erba Diagnostics partnerships and signals

Strategic signal

Recent moves1 record

Expansion highlights1 record

Erba Diagnostics competitors and assessment

Company assessment

Direct peers

  • Bio-Rad Laboratories: Mid-to-large diversified life science and clinical diagnostics manufacturer producing IVD reagents, test kits, and clinical instrumentation. Closely comparable product mix and customer base (hospital and reference labs).
  • QuidelOrtho: IVD specialist focused on immunoassays, molecular diagnostics reagents, and rapid diagnostic kits. Direct overlap in proprietary diagnostic reagent and kit manufacturing serving clinical laboratories.
  • DiaSorin: Specialty IVD company producing proprietary reagent kits and dedicated immunoassay instrumentation. Comparable reagent-instrument integration model and focus on specialty diagnostics.
  • Hologic: Diagnostics segment manufacturer of molecular and immunoassay reagents, kits, and instruments (e.g., Panther system). Comparable proprietary reagent-and-instrument stack for clinical labs.

Emerging players

  • Mindray: China-based IVD and patient monitoring manufacturer expanding globally with reagent kits and clinical chemistry / hematology analyzers. Comparable reagent-instrument portfolio at a lower price point targeting mid-tier labs.
  • Sysmex: Hematology and specialty IVD player with proprietary reagent menus and analyzers. Comparable reagent-instrument integration model, especially in clinical lab segments outside the largest US hospitals.

Broad incumbents

  • Roche Diagnostics: Global IVD market leader offering the broadest reagent and instrument portfolio (cobas, Elecsys). Sets competitive benchmarks on assay menu, instrument throughput, and pricing.
  • Abbott Diagnostics: Major IVD incumbent with Alinity and ARCHITECT reagent-instrument platforms spanning immunoassay, clinical chemistry, and molecular diagnostics. Dominant share of US hospital lab contracts.
  • Siemens Healthineers: Diversified diagnostics manufacturer offering Atellica and ADVIA Centaur reagent/instrument systems. Major competitor in mid-to-large hospital and reference lab channels.
  • Beckman Coulter (Danaher): Clinical chemistry, immunoassay, and hematology reagent-and-instrument vendor within Danaher's diagnostics platform. Direct overlap with ERBA's reagents + instrumentation stack.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks4 records

Key highlights4 records

Customer concentration

Erba Diagnostics financial estimates

Financial estimate

Revenue estimate

Valuation estimate

Erba Diagnostics leadership team

Management profile

Number of profiles

Erba Diagnostics funding detail

Funding detail

Funding overview

Funding rounds1 record

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

Erba Diagnostics M&A and investment

M&A and investment

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Erba Diagnostics

What does Erba Diagnostics do?

ERBA Diagnostics manufactures and markets proprietary diagnostic reagents, test kits, and instrumentation used by clinical laboratories. Its offering combines consumable diagnostic chemistries with the analytical instruments that run them, supporting routine in-vitro diagnostic testing in hospital, reference, and clinical laboratory settings.

When was Erba Diagnostics founded?

Erba Diagnostics was founded in 2001. It employs 101 to 250 people.

Where is Erba Diagnostics based?

Erba Diagnostics is headquartered in Miami, United States, in the North America region.

Who are Erba Diagnostics's main competitors?

Direct peers on record are Bio-Rad Laboratories, QuidelOrtho, DiaSorin and Hologic. Emerging players are Mindray and Sysmex. Broad incumbents are Roche Diagnostics, Abbott Diagnostics, Siemens Healthineers and Beckman Coulter (Danaher).

Does Erba Diagnostics have an API?

No public API is recorded for Erba Diagnostics.

What industry is Erba Diagnostics in?

Erba Diagnostics's product category is In-Vitro Diagnostics. Its primary akta.pro industry code is HLAHAAAM, IVD Reagents, Assay Kits & Consumables (Non-instrument). Its NAICS code is 325413 and its SIC code is 2835.

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Live signals
PR NewswireERBA Diagnostics, Inc. Appoints David Barka as Interim Chief Executive Officer, Nikhil Vazirani as Member of the BoardERBA Diagnostics, Inc. appointed David Barka as Interim Chief Executive Officer and Nikhil Vazirani to its Board of Directors, effective August 1, 2017. Both executives will retain their existing roles within the Erba Mannheim group, which holds approximately 83.3% of ERBA Diagnostics' outstanding shares.PR NewswireResearch and Markets - Global Antinuclear Antibody Test Market Worth $1,476.1 Million by 2021 - Key Players are Bio-Rad Laboratories, ERBA Diagnostics & Trinity BiotechResearch and Markets announced the addition of a new report forecasting the global antinuclear antibody (ANA) testing market to reach USD 1,476.1 million by 2021. The report identifies key industry players including Bio-Rad Laboratories, ERBA Diagnostics, and Trinity Biotech as central to this growing sector driven by autoimmune disease prevalence.GlobeNewswireERBA Diagnostics, Inc. Announces Inability to Meet Deadline to Regain Compliance With NYSE MKT Continued Listing StandardsERBA Diagnostics, Inc. announced it cannot meet its November 25, 2016 deadline to regain compliance with NYSE MKT listing standards. The company expects trading in its common stock to be suspended and delisting procedures initiated. It plans to disclose a delisting notice after receipt.GlobeNewswireERBA Diagnostics, Inc. Announces Notice of Noncompliance With NYSE MKT Continued Listing StandardsERBA Diagnostics received a notice from NYSE MKT that it is noncompliant with listing standards because it failed to file its Q2 2016 10-Q. The company has a remediation plan with a deadline of November 25, 2016, and failure to regain compliance could lead to delisting.GlobeNewswireERBA Diagnostics, Inc. Announces Extension of CEO’S Contract Term and Appointment of Hayden Jeffreys to Board of DirectorsERBA Diagnostics extended CEO Mohan Gopalkrishnan's contract to December 31, 2016, and appointed Hayden Jeffreys to its board. Jeffreys brings 20 years of clinical diagnostics experience and currently serves as Commercial Director for the Molecular Diagnostics Division.GlobeNewswireERBA Diagnostics, Inc. Announces Notice of Noncompliance With NYSE MKT Continued Listing StandardsERBA Diagnostics received a NYSE MKT notice of noncompliance on April 15, 2016, for failing to file its 2015 annual 10-K. The Exchange may delist the company if it does not regain compliance by May 25, 2016, and the company plans to restate prior-year financials.PR NewswireSHAREHOLDER ALERT: ERBA Diagnostics, Inc. ("ERB") is the Subject of a Legal InvestigationWeissLaw LLP announced an investigation into ERBA Diagnostics, Inc. for possible breaches of fiduciary duty and federal securities law violations, stemming from the company's November 2015 admission that its financial statements for 2013, 2014, and portions of 2015 contain material weaknesses and should not be relied upon. The Audit Committee investigation found errors across the past ten quarters, with an expected increase in net loss of $3.0–4.0 million, causing shares to drop approximately 20% from $1.74 to $1.44. Following the financial restatement announcement, ERB also faces potential suspension and delisting from the New York Stock Exchange, with the share price falling to a 52-week low of $0.95 on January 25, 2016.PR NewswireSHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in ERBA Diagnostics, Inc. of Class Action Lawsuit and Upcoming Deadline - ERBPomerantz LLP filed a securities class action lawsuit against ERBA Diagnostics, Inc. in the U.S. District Court for the Southern District of Florida on behalf of investors who purchased ERBA securities between April 14, 2014 and November 23, 2015. The complaint alleges the company made false and misleading statements regarding inadequate financial reporting controls and materially false financial statements. Following ERBA's November 20, 2015 disclosure that its previously issued financial statements should no longer be relied upon and would be restated, the company's shares fell $0.30, or over 17%, to close at $1.44 on November 23, 2015.GlobeNewswireUPCOMING DEADLINE ALERT: Brower Piven Encourages Investors Who Have Losses in Excess of $100,000 From Investment in ERBA Diagnostics, Inc. to Contact Brower Piven Before the Lead Plaintiff Deadline inBrower Piven announced a securities class action against ERBA Diagnostics, covering purchases from April 14, 2014 to November 23, 2015. Investors with losses over $100,000 have until February 1, 2016 to seek lead-plaintiff appointment. The complaint alleges failure to disclose inadequate financial reporting controls.PR NewswireLifshitz & Miller Law Firm Announces Investigation of BofI Holding, Inc., Capstone Turbine Corporation, Dr. Reddy's Laboratories Ltd., ERBA Diagnostics, Inc., Identiv, Inc., Osiris Therapeutics, Inc.,Lifshitz & Miller Law Firm announced investigations into eight publicly traded companies—BofI Holding, Capstone Turbine, Dr. Reddy's Laboratories, ERBA Diagnostics, Identiv, Osiris Therapeutics, and XBiotech—for potential breaches of fiduciary duties or financial irregularities. The announcements follow specific corporate events, including whistleblower lawsuits, FDA warning letters, financial restatements, auditor resignations, and revenue recognition corrections. These inquiries signal potential legal liabilities for the boards of these entities regarding their internal controls and reporting accuracy.