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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• Miscellaneous Accessories

• MSDS Resource Kits

• Multiple Biochemical Test Culture Media (FDA Code: JSE / 866.2320) A differential culture medium is a device that consists primarily of liquid biological materials intended for medical purposes to cultivate and identify different types of pathogenic microorganisms. The identification of these microorganisms is accomplished by the addition of a specific biochemical component(s) to the medium. Microorganisms are identified by a visible change (e.g., a color change) in a specific biochemical component(s) which indicates that specific metabolic reactions have occurred. Test results aid in the diagnosis of disease and also provide epidemiological information on diseases caused by these microorganisms.

• Neurology Instruments

• Nitrile Examination Disposable Gloves

• Non-Propagating Transport Culture Media (FDA Code: JSM / 866.2390) A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.

• Non-Selective and Differential Culture Media (FDA Code: JSH / 866.2320)

• Non-Selective and Non-Differential Culture Media (FDA Code: JSG / 866.2300) A multipurpose culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes for the cultivation and identification of several types of pathogenic microorganisms without the need of additional nutritional supplements. Test results aid in the diagnosis of disease and also provide epidemiological information on diseases caused by these microorganisms.

• Parasite Concentration Analyzer (FDA Code: LKS / 866.2900) A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

• Pathogenic Neisseria Culture Media (FDA Code: JTY / 866.2410) A culture medium for pathogenicNeisseria spp. is a device that consists primarily of liquid or solid biological materials used to cultivate and identify pathogenicNeisseria spp. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusNeisseria, such as epidemic cerebrospinal meningitis, other meningococcal disease, and gonorrhea, and also provides epidemiological information on these microorganisms.

• Petri Plates

• Phlebotomy Needles & Tourniquets

• Pipettes & Tips

• Pregnancy Kits

• Pregnancy Testing Kits

• Preps & Swabs

• Proficiency Testing

• Quality Assessment Programs

• Selective and Differential Culture Media (FDA Code: JSI / 866.2360) A selective culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate and identify certain pathogenic microorganisms. The device contains one or more components that suppress the growth of certain microorganisms while either promoting or not affecting the growth of other microorganisms. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.

• Selective and Non-Differential Culture Media (FDA Code: JSJ / 866.2360)

• Selective Broth Culture Media (FDA Code: JSD / 866.2360)

• Sensitive Pregnancy Tests

• Sensitivity Supplies

• Single Biochemical Test Culture Media (FDA Code: JSF / 866.2320)

• Specimen Collection & Shipping

• Specimen Collection Kits

• Surgical Gloves

• Susceptibility Test Kits

• Swabs

• Swabs, Absorbing

• Tourniquets

• Towels

• Towels & Wipes

• Transport Service, Couriers

• Urinalysis Kits

• Urinalysis Reagents & Test Strips