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Biogenex Laboratories

10 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System; Model Number/Ca recall (Z-1016-2010)Biogenex Laboratories2010-03-08
Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System, Catalog number recall (Z-1471-2008)Biogenex Laboratories2008-08-22
Super Sensitive Link-Label IHC Detection System/Mega Volume, RTU Multi-Link-HRP, REF/Cat. recall (Z-0217-2007)Biogenex Laboratories2006-12-08
Anti-CD45 Cocktail antibody in 6 ml vials; Cat. No. AM371-5M , manufactured and distribute recall (Z-1519-06)Biogenex Laboratories2006-09-23
BioGenex brand Hepatitis B Virus Core Antigen Antibody, Cat. No. AR082-5R and PU082-UP, Pr recall (Z-1438-06)Biogenex Laboratories2006-08-29
BioGenex brand Hepatitis B Virus Surface Antigen Antibody, Cat. No. AM364-5M and MU364-UC, recall (Z-1439-06)Biogenex Laboratories2006-08-29
Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is be recall (Z-0606-06)Biogenex Laboratories2006-03-15
Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is be recall (Z-0607-06)Biogenex Laboratories2006-03-15
Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is be recall (Z-0608-06)Biogenex Laboratories2006-03-15
Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is be recall (Z-0609-06)Biogenex Laboratories2006-03-15

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Every clearance here is in the API, with alerts when new ones post.