4 results
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6ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Iii
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Assayed Bovine Multi-Sera Level 1, Model No. AL1027
FDA Enforcement
Class III
·Terminated·Randox Laboratories, Limited·August 14, 2019
Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera.
FDA Enforcement
Class III
·Terminated·Clark Laboratories, Inc. (dba,Trinity Biotech USA)·October 3, 2012
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
CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Description Carcinoembryonic antigen (CEA), is synthesized during development in the fetal gut, and is re-expressed in increased amounts in intestinal carcinomas and several other tumors. Antibody to CEA is reportedly useful in identifying the origin of various metastatic adenocarcinomas and in distinguishing pulmonary adenocarcinomas (60-70% are CEA+) from pleural mesotheliomas (rarely or weakly CEA+). This product is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin-embedded tissue sections, to be viewed by light microscopy.
FDA Enforcement
Class III
·Terminated·Lab Vision Corporation·February 24, 2016