Immuno-mycologies Inc

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Web: http://www.immy.com
E-Mail:
Address: PO Box 1151, Norman, Oklahoma 73070, USA
Phone: +1-(800)-654-3639 | Fax: +1-(405)-288-2228 | Map/Directions >>

Profile: Immuno-mycologies Inc produces fungal diagnostic products. We concentrate on systemic mycoses. Our product line includes cryptococcus neoformans, coccidiodes immitis, histoplasma capsulatum, candida albicans, sporothrix schenckii, blastomyces dermatitidis, aspergillus fumigatus and paracoccidioides.

The company was founded in 1979, has revenues of < USD 1 Million, has ~10 employees.

FDA Registration Number: 1627497

37 Products/Services (Click for related suppliers)

• Analyte Specific Reagents, Asr Reagents (FDA Code: MVU / 864.4020)

Analyte specific reagents (ASR's) are antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens. ASR's that otherwise fall within this definition are not within the scope of subpart E of this part when they are sold to:

• Antibody Detection Candida Species (FDA Code: LSG / 866.3165)

• Aspergillus Spp CF Antigen (FDA Code: JWT / 866.3040)

• Aspergillus Spp. Positive Control Antiserum (FDA Code: KFG / 866.3040)

• Aspergillus Test Kits

• B. Dermatitidis Antigen (FDA Code: JWW / 866.3060)

• Blastomyces Dermatitidis Antigen (FDA Code: LSH / 866.3060)

• Blastomyces Dermatitidis EIA (FDA Code: MJL / 866.3060)

• Blastomyces Dermatitidis Positive Control Antiserum Test (FDA Code: KFH / 866.3060)

• Candida Albicans ID Antigen (FDA Code: LHK / 866.3165)

• Coccidioides Immitis CF and ID Antigen (FDA Code: GMI / 866.3135)

• Coccidioides Immitis Enzyme Linked Immunoabsorbent Assay (FDA Code: MIY / 866.3135)

• Coccidioides Immitis Latex Agglutination Antigen Test (FDA Code: GMG / 866.3135)

• Coccidioides Immitis Positive Control Antiserum Test (FDA Code: GMH / 866.3135)

• Cryptococcus Antigen Enzyme Linked Immunoabsorbent Assay Antigen (FDA Code: MDU / 866.3165)

• Cryptococcus Neoformans Positive Control Antigen Test (FDA Code: JWK / 866.3165)

• 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.

• Diagnostic Products

• Enzyme Immunoassay Test

• General Purpose Reagent (FDA Code: LDT)

• Hepatitis B Antigen Identification System (FDA Code: KSJ)

• Histoplasma Capsulatum Antigen (FDA Code: GMJ / 866.3320)

• Histoplasma Capsulatum Enzyme Linked Immunoabsorbent Assay (FDA Code: MIZ / 866.3320)

• Histoplasma Capsulatum Positive Control Antiserum Test (FDA Code: GMK / 866.3320)

• Histoplasma Capsulatum Reagent (FDA Code: MBT / 866.3320)

• 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.

• Id Direct Antigen Candida Spp. (FDA Code: LRF / 866.3165)

• Immunodiffusion Equipment

• Latex Agglutination Test for Cryptococcus neoformans (FDA Code: GMD / 866.3165)

• Microbiology Identification Test Kits

• Other Blastomyces Dermatitidis Antiserum (FDA Code: LSI / 866.3060)

• Ouchterlony Agar Plate Test (FDA Code: JZP / 866.4600)

An ouchterlony agar plate for clinical use is a device containing an agar gel used to examine antigen-antibody reactions. In immunodiffusion, antibodies and antigens migrate toward each other through gel which originally contained neither of these reagents. As the reagents come in contact with each other, they combine to form a precipitate that is trapped in the gel matrix and is immobilized.

• Positive and Negative Febrile Antigen Control Serum (FDA Code: GSN / 866.3085)

• Radial Immunodiffusion Plates and Equipment (FDA Code: JZQ / 866.4800)

A radial immunodiffusion plate for clinical use is a device that consists of a plastic plate to which agar gel containing antiserum is added. In radial immunodiffusion, antigens migrate through gel which originally contains specific antibodies. As the reagents come in contact with each other, they combine to form a precipitate that is trapped in the gel matrix and immobilized.

• Sporothrix Schenekii Fluorescent Antisera (FDA Code: GMA / 866.3680)

• Staphylococcus Aureus Screening Kit (FDA Code: JWX / 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.

• Yeast Screening Kit (FDA Code: JXC / 866.2660)