Device Description : Self-contained media system for the recovery and detection of T. vaginalis from Self-contained media system for the recovery and detection of T. vaginalis from female vaginal samples or male urethra/urine samples.
Device Class :
Duns Number: 605213545
Premarket Exempt : No
Prescription Use : No
Device Description : A highly selective growth medium which maintains viable Trichomonas vaginalis cu A highly selective growth medium which maintains viable Trichomonas vaginalis cultures (positive controls) for up to seven (7) days.
Device Class :
Duns Number: 605213545
Premarket Exempt : Yes
Prescription Use : No
Device Description : Intended for use in the qualitative detection of oral, rectal and genitourethral Intended for use in the qualitative detection of oral, rectal and genitourethral Neisseria gonorrhoeae colonization.
Device Class :
Duns Number: 605213545
Premarket Exempt : No
Prescription Use : Yes
Device Description : For rapid isolation and differentiation of urinary tract pathogens. Suitable for For rapid isolation and differentiation of urinary tract pathogens. Suitable for direct plating of urine specimens.
Device Class :
Duns Number: 605213545
Premarket Exempt : Yes
Prescription Use : No
Device Description : For isolation and differentiation of major clinically significant Candida specie For isolation and differentiation of major clinically significant Candida species. Suitable for direct streaking of samples from skin,sputum, urine or genitourinary swabs.
Device Class :
Duns Number: 605213545
Premarket Exempt : Yes
Prescription Use : No
Device Description : A chromogenic medium for selective isolation and differentiation of Salmonella s A chromogenic medium for selective isolation and differentiation of Salmonella species, (e.g., Enterobacteriaceae and other enteric bacteria).The test can be performed with samples composed of mixed populations of bacteria, e.g stool, blood, biological fluids, surface streaks, etc. High sensitivity and specificity of the medium lead to a higher detection rate of Salmonella spp. Selective agents inhibit the growth of gram-positive organisms. Artificial substrates are metabolized by specific microbial enzymes liberating insoluble chromogenic compounds. Salmonella species produce deep pink to mauve colored colonies. Bacteria other than Salmonella spp. produce blue colonies, or are colorless or inhibited.
Device Class :
Duns Number: 605213545
Premarket Exempt : Yes
Prescription Use : No
Device Description : A general-purpose medium for the cultivation of pathogenic and non-pathogenic fu A general-purpose medium for the cultivation of pathogenic and non-pathogenic fungi, including dermatophytes. The low pH (approximately 5.6) is favorable for growth of fungi, especially yeasts and dermatophytes. Sabouraud's Dextrose Agar (SAB) is slightly inhibitory to contaminating bacteria in clinical specimens.
Device Class :
Duns Number: 605213545
Premarket Exempt : Yes
Prescription Use : No
Device Description : Recommended by the American Public Health Association for plate counts of yeasts Recommended by the American Public Health Association for plate counts of yeasts and molds in the examination of foods and dairy products, it is also used for maintenance, cultivation and sporulation of stock cultures of various dermatophytes and for differentiation of atypical varieties of dermatophytes by pigment production.
Device Class :
Duns Number: 605213545
Premarket Exempt : Yes
Prescription Use : No
Device Description : Mannitol Salt Agar (MSA) test uses a selective isolation media for the enumerati Mannitol Salt Agar (MSA) test uses a selective isolation media for the enumeration of staphylococci from clinical/non-clinical materials. A change of the phenol red indicator (Mannitol fermentation) aids in differentiating staphylococci species.
Device Class :
Duns Number: 605213545
Premarket Exempt : Yes
Prescription Use : No
Device Description : A nutrient-rich medium for the use of cultivation, isolation and enumeration of A nutrient-rich medium for the use of cultivation, isolation and enumeration of a broad-spectrum of environmental and pathogenic yeasts and molds. The device can accept samples by direct plating or interface directly with standard methods for microbial testing of water samples using the Membrane Filter (MF) Technique1. The acidic pH of Malt Extract Agar allows for the optimal growth of molds and yeasts while restricting bacterial growth.
Device Class :
Duns Number: 605213545
Premarket Exempt : Yes
Prescription Use : No