6 results
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19ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Iii
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Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder is prepared and standardized for use in microbiological culture media, where it is generally used to replace infusion of meat. Culture media containing Beef Extract Powder are recommended for use in bacteriological examination of water, milk, and other materials, where uniform composition of media is important. Beef Extract Powder is relied upon for biochemical studies, particularly fermentation reactions because of its independence from ferment-able substances. Several media containing Beef Extract Powder are recommended in standard methods for multiple application.
FDA Enforcement
Class III
·Terminated·Acumedia Manufacturers, Inc.·June 7, 2017
Nutrient Gelatin, Acumedia Part Number 7471 A Product Usage: Nutrient Gelatin is used for the differentiation of microorganisms on the basis of gelatinase production. Identifying fermentative and non-fermentative Gram-negative bacilli include testing for gelatin liquefaction. If the proteolytic enzyme gelatinase is present, gelatin is hydrolyzed and loses its gelling characteristic.
FDA Enforcement
Class III
·Terminated·Acumedia Manufacturers, Inc.·June 7, 2017
Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the isolation of fungi from surfaces sanitized with quaternary ammonium compounds
FDA Enforcement
Class III
·Terminated·Acumedia Manufacturers, Inc.·June 7, 2017
Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production
FDA Enforcement
Class III
·Terminated·Acumedia Manufacturers, Inc.·June 14, 2017
Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with supplements as a selective and differential medium for the detection and isolation of Listeria monocytogenes from foods and environmental samples in a laboratory setting. Not intended for use in the diagnosis of disease or other conditions in humans.
FDA Enforcement
Class III
·Terminated·Acumedia Manufacturers, Inc.·November 7, 2018
Campylobacter Blood Free Selective Medium, PN 7527A Used with cefoperazone for the selective isolation of Campylobacter spp. In a laboratory setting. Not intended for use in the diagnosis of disease or other conditions in humans.
FDA Enforcement
Class III
·Terminated·Acumedia Manufacturers, Inc.·November 7, 2018