HealthLink

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Web: http://www.healthlinkinc.net
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Address: 3611 St John's Bluff Rd South, Suite 1, Jacksonville, Florida 32224, USA
Phone: +1-(800)-638-2625 | Map/Directions >>
 
 

Profile: HealthLink is a medical manufacturer. We offer a wide range of medical lamps & batteries, stains & reagents and biological indicators. We manufacture a complete line of prepared culture media. This includes not only plated media, but also tubed & bottled media. We also offer a complete line of infection control products. ProTest Steam is a self contained biological indicator inoculated with viable geobacillus stearothermophilus bacterial spore & is intended for monitoring the efficacy of steam sterilization cycles. Each ProTest Steam plastic vial has a vial label indicating intended sterilization process, lot number and expiration date. A process chemical indicator ink is printed on each vial label in order for users to identify processed & unprocessed vials. Our product aloesoothe® is the perfect moisturizing lotion. It moisturizes & helps seal out harsh irritants while allowing for the body's natural healing process. It also helps prevent chapping & irritation caused by frequent hand washing and regular use of latex gloves.

FDA Registration Number: 1059020

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• Automated Hematology Analyzers
• Biopsy Punches (FDA Code: FCI / 876.1075)
A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
• Blood Analyzer Reagents
• Blood, Hematology Analyzers
• Bone Curettes
• Clinical Mercury Thermometers (FDA Code: FLK / 880.2920)
A clinical mercury thermometer is a device used to measure oral, rectal, or axillary (armpit) body temperature using the thermal expansion of mercury.
• Controls
• Culture Media Quality Control Kit (FDA Code: JTR / 866.2480)
A quality control kit for culture media is a device that consists of paper discs (or other suitable materials), each impregnated with a specified, freeze-dried, viable microorganism, intended for medical purposes to determine if a given culture medium is able to support the growth of that microorganism. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.
• Curettes
• Deodorizers & Air Fresheners
• Diagnostic Aids
• Digital Thermometers
• Disinfect & Cleaning Solution
• Ear Micro Curettes
• Ear Thermometers
• Enriched Culture Media (FDA Code: KZI / 866.2330)
An enriched culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate and identify fastidious microorganisms (those having complex nutritional requirements). The device consists of a relatively simple basal medium enriched by the addition of such nutritional components as blood, blood serum, vitamins, and extracts of plant or animal tissues. The device is used in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.
• Forehead Thermometers
• General Diagnostic Supplies
• General Diagnostics
• General Examination Supplies
• General Medical Supplies
• 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.
• General Surgery Supplies
• General Surgical Manual Instrument (FDA Code: MDM / 878.4800)
A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.
• General Systemics
• Hand Cleaners & Disinfectants
• Hematology Analyzers
• Infectious Disease Exams
• Infectious Disease Testing Viral Quality Control kits
• Laboratory Hematology Analyzers
• Long Handle Curettes
• Micro Axial Curettes
• Microbiology Diagnostic Device (FDA Code: LIB / 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.
• Microbiology Kit
• Miscellaneous Deodorizers
• Miscellaneous Externals
• Mueller Hinton Agar Broth Culture Media (FDA Code: JTZ / 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.
• Multichannel Hematology Analyzers
• Non-Mercury Thermometers
• Non-Selective and Differential Culture Media (FDA Code: JSH / 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.
• 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.
• Otoscope Aids
• 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.
• Quality Control Kits (FDA Code: JTR / 866.2480)
• Refurbished Hematology Analyzers
• 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)
• Sensitivity Supplies
• Smaller Hematology Analyzers

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