Profile: Hardy Diagnostics manufactures over 2,800 products used for the culture and identification of bacteria & fungi. We are accredited with ISO: 13485 certification. Our product line includes rapid test kits, prepared media (plates, tubes, bottles, and flasks) and dehydrated culture media in the powder form, known as CRITERION&trade. Our clinical products list comprises of Rapid Ornithine, GlabrataQuick™ Kit, CVM Transport Dynamic Duo, and HardyCHROM™ MRSA CP. The GlabrataQuick™ Kit provides a rapid test for the identification of Candida (Torulopsis) glabrata. It uses acid production from three carbohydrates to identify Candida glabrata in one to two hours. It decreases the number of false positives due to the addition of two additional key sugar fermentation reactions besides trehalose. Its set-up takes less than two minutes.

The company was founded in 1980, has revenues of USD 10-25 Million, has ~100 employees.

FDA Registration Number: 2022807

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• Antimicrobial Susceptibility Test Culture Media (FDA Code: JSO / 866.1700) A culture medium for antimicrobial susceptibility tests is a device intended for medical purposes that consists of any medium capable of supporting the growth of many of the bacterial pathogens that are subject to antimicrobial susceptibility tests. The medium should be free of components known to be antagonistic to the common agents for which susceptibility tests are performed in the treatment of disease.

• Antimicrobial Susceptibility Test Disc (FDA Code: JTN / 866.1620) An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

• Blood Bank Test Kits

• Blood Culture Instruments

• Blood Culture Test Kits

• Blood glucose testing

• Clinical Microscopes

• Clinical Sample Concentrator (FDA Code: JJH / 862.2310) A clinical sample concentrator is a device intended to concentrate (by dialysis, evaporation, etc.) serum, urine, cerebrospinal fluid, and other body fluids before the fluids are analyzed.

• Coagulation Test Kits

• Compliance Resources, Clinical Lab

• Cotton Swabs

• Culture Media Supplements (FDA Code: JSK / 866.2450) A supplement for culture media is a device, such as a vitamin or sugar mixture, that is added to a solid or liquid basal culture medium to produce a desired formulation and that is intended for medical purposes to enhance the growth of fastidious microorganisms (those having complex nutritional requirements). This device aids in the diagnosis of diseases caused by pathogenic microorganisms.

• Cytology Test Stains

• Diagnostic Test Kits For Pregnancy

• Disposable Examination Gloves

• Disposable Examination Latex Gloves

• Disposable Examination Nitrile Gloves

• Disposable Gloves

• Early Pregnancy Testing Kit

• Exam Gloves

• Eyes & Face Protection Kits

• General Nutrient Broth Culture Media (FDA Code: JSC / 866.2350) A microbiological assay culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate selected test microorganisms in order to measure by microbiological procedures the concentration in a patient's serum of certain substances, such as amino acids, antimicrobial agents, and vitamins. The concentration of these substances is measured by their ability to promote or inhibit the growth of the test organism in the innoculated medium. Test results aid in the diagnosis of disease resulting from either deficient or excessive amounts of these substances in a patient's serum. Tests results may also be used to monitor the effects of the administration of certain antimicrobial drugs.

• Glassware

• Glucose

• Glucose Analyzers

• Glucose Kits

• Glucose Test Kits

• Hematology Kits

• Hematology Slide Stainer Instruments

• Histology Test Kits

• Home pregnancy test kits, Hcg

• Human/Horse/Rabbit Coagulase Plasma (FDA Code: JTL / 866.2160) Coagulase plasma is a device that consists of freeze-dried animal or human plasma that is intended for medical purposes to perform coagulase tests primarily on staphylococcal bacteria. When reconstituted, the fluid plasma is clotted by the action of the enzyme coagulase which is produced by pathogenic staphylococci. Test results are used primarily as an aid in the diagnosis of disease caused by pathogenic bacteria belonging to the genusStaphylococcus and provide epidemiological information on disease caused by these microorganisms.

• Immersion Type Slide Stainer (FDA Code: KIO / 864.3800) An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.

• Infectious Disease Identification Test Kits

• Infectious Disease Test Kits

• Lab Coats

• Lab Coats, Uniforms

• Laboratory Glassware

• Latex Disposable Gloves

• Medical Gloves

• Medical Gloves

• Microbiology Identification Instruments

• Microbiology Identification Test Kits

• Microbiology PCR Instruments

• Microbiology Susceptibility Instruments

• Microorganism Differentiation Strip and Reagent Disc (FDA Code: JTO / 866.2660) A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

• Microscope Slides (FDA Code: KEW / 864.3010) Tissue processing equipment consists of devices used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides.

• Microscope Slides (FDA Code: KEW / 864.3010)

• Microscopes

• Microscopes & Telescopes