Device Description : a selective and differential media for the detection of sorbitol-non-fermenting a selective and differential media for the detection of sorbitol-non-fermenting Escherichia coli serotype O157:H7 associated with hemorrhagic colitis. This medium is also referred to as "MacConkey Sorbitol Agar."
Device Class :
Duns Number: 605213545
Premarket Exempt : Yes
Prescription Use : No
Device Description : A non-selective medium used for isolation, cultivation and enumeration of non-fa A non-selective medium used for isolation, cultivation and enumeration of non-fastidious and fastidious microorganisms. The device is designed to interface directly with standard methods for bacterial testing of water samples using the Membrane Filter (MF) Technique.
Device Class :
Duns Number: 605213545
Premarket Exempt : Yes
Prescription Use : No
Device Description : Highly selective medium for the isolation of Salmonella other than S. typhi from Highly selective medium for the isolation of Salmonella other than S. typhi from feces and other materials.
Device Class :
Duns Number: 605213545
Premarket Exempt : Yes
Prescription Use : No
Device Description : A medium devised for selection of non-typhi Salmonella from samples contaminated A medium devised for selection of non-typhi Salmonella from samples contaminated with fecal matter. Growth of other organisms is inhibited and Salmonella can be differentiated from other organisms by colony color.
Device Class :
Duns Number: 605213545
Premarket Exempt : Yes
Prescription Use : No
Device Description : Agar is a general purpose nutrient medium recommended for the cultivation and is Agar is a general purpose nutrient medium recommended for the cultivation and isolation of a variety of microorganisms, including bacteria, yeasts, and molds.
Device Class :
Duns Number: 605213545
Premarket Exempt : Yes
Prescription Use : No
Device Description : InTray® DM-FungID™ is an enriched dermatophyte medium used to aid in the detecti InTray® DM-FungID™ is an enriched dermatophyte medium used to aid in the detection of dermatophytes from clinical specimens with mixed micobiota.
Device Class :
Duns Number: 605213545
Premarket Exempt : Yes
Prescription Use : No
Device Description : The VTM-C19 Transit Tube contains a viral transport medium (VTM) intended to be The VTM-C19 Transit Tube contains a viral transport medium (VTM) intended to be inoculated with nasopharyngeal (NP) or oropharyngeal (OP) synthetic fiber swab specimens (Not provided), transported appropriately to the lab and analyzed with validated qRT-PCR assays for the detection of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that causes COVID-19 disease in humans. Manufacturers Note: Under enforcement discretion, we are currently exempt of having 510(k) during emergency and threat of Covid.
Device Class :
Duns Number: 605213545
Premarket Exempt : Yes
Prescription Use : No
Device Description : Saline Solution (0.85%) is a saline solution for viral specimens.
Device Class :
Duns Number: 605213545
Premarket Exempt : Yes
Prescription Use : No
Device Description : An enriched dermatophyte medium used in the detection of dermatophytes from clin An enriched dermatophyte medium used in the detection of dermatophytes from clinical specimens.
Device Class :
Duns Number: 605213545
Premarket Exempt : Yes
Prescription Use : No
Device Description : Mueller Hinton Chocolate Agar is presented in a cassette-like device with indivi Mueller Hinton Chocolate Agar is presented in a cassette-like device with individual seal and label for use in qualitative procedures for the isolation and cultivation of fastidious organisms, particularly Haemophilus species. InTray Mueller Hinton Chocolate agar contains beef extract, vitamins and mineral enrichment, acid hydrolysate of casein, cystine, tryptophan, starch, agar and hemoglobin. Agar appears chocolate brown with a final pH of 7.3 ± 0.2 at 25°C.
Device Class :
Duns Number: 605213545
Premarket Exempt : Yes
Prescription Use : No