""ISO 13485"" — Epstein Files Search

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8 results for “"ISO 13485"”

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EFTA00675936Set 9

2013-11-122p697w

facility features BL-2 laboratory space and GMP manufacturing in compliance with FDA and ISO 13485 standards. *MMWR Weekly Report "Vital Signs: Preventing Clostridium difficile Infections" March ... oncology and human genetics, as well as next generation instrument systems. IMDx facilities are ISO 13485:2003 certified and all products are developed and manufactured within a regulatory compliant

https://www.justice.gov/epstein/files/DataSet%209/EFTA00675936.pdf

EFTA00703494Set 9

2013-07-302p647w

diseases, STDs, prenatal testing), oncology and other human genetic targets. The IMDx facilities are ISO 13485:2003 certified and all of the IMDx products are developed and manufactured within

https://www.justice.gov/epstein/files/DataSet%209/EFTA00703494.pdf

EFTA00747269Set 9

2010-03-242p679w

IMDx assay solutions are designed, developed and manufactured to be compliant with FDA, ISO 13485 and IVDD regulations and guidances. IMDx tests are designed to be clinically impactful, competitively differentiated

https://www.justice.gov/epstein/files/DataSet%209/EFTA00747269.pdf

EFTA00662732Set 9

2014-05-082p680w

oncology and human genetics, as well as next generation instrument systems. IMDx facilities are ISO 13485:2003 certified and all products are developed and manufactured within a regulatory compliant

https://www.justice.gov/epstein/files/DataSet%209/EFTA00662732.pdf

EFTA00761710Set 9

2010-03-242p563w

IMDx assay solutions are designed, developed and manufactured to be compliant with FDA, ISO 13485 and IVDD regulations and guidances. IMDx tests are designed to be clinically impactful, competitively differentiated

https://www.justice.gov/epstein/files/DataSet%209/EFTA00761710.pdf

EFTA00761695Set 9

2010-03-242p631w

IMDx assay solutions are designed, developed and manufactured to be compliant with FDA, ISO 13485 and IVDD regulations and guidances. IntelligentMDx tests are designed to be clinically impactful, competitively differentiated

https://www.justice.gov/epstein/files/DataSet%209/EFTA00761695.pdf

EFTA00605649Set 9

oncology and human genetics, as well as next generation instrument systems. IMDx facilities are ISO 13485:2003 certified and all products are developed and manufactured within a regulatory compliant

https://www.justice.gov/epstein/files/DataSet%209/EFTA00605649.pdf

EFTA00747252Set 9

2010-03-242p742w

IMDx assay solutions are designed, developed and manufactured to be compliant with FDA, ISO 13485 and IVDD regulations and guidances. IntelligentMDx tests are designed to be clinically impactful, competitively differentiated

https://www.justice.gov/epstein/files/DataSet%209/EFTA00747252.pdf

Corpus: 1990-03-17 – 2025-12-01

November 2013

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Results by Dataset8 total

Set 9

8