INFINITI® Factor V Leiden BioFilmChip® Microarray Magazine

FDA UDI

AUTOGENOMICS, INC·00850009370075·Genotyping system for the detection of the Fac...

INFINITI Warfarin Assay

FDA registration

AUTOGENOMICS, INCORPORATED·3 products·🇺🇸 United States

Aptima Controls Kit

FDA registration

Hologic, Inc.·3 products·🇺🇸 United States

Aptima BV assay

FDA registration

Hologic, Inc.·3 products·🇺🇸 United States

Aptima Controls Kit

FDA registration

Hologic, Inc.·3 products·🇺🇸 United States

FilmArray Meningitis/Encephalitis (ME) Panel

FDA registration

BioFire Diagnostics, LLC·3 products·🇺🇸 United States

Clinical sample concentrator

FDA registration

MONOCENT INC.·3 products·🇺🇸 United States

Gastrointestinal Pathogen Panel (GPP)

FDA registration

Luminex Corporation·3 products·🇺🇸 United States

Gastrointestinal Pathogen Panel (GPP)

FDA registration

LUMINEX MOLECULAR DIAGNOSTICS, INC.·3 products·🇨🇦 Canada

Aptima Controls Kit

FDA registration

HOLOGIC, LTD.·3 products·🇬🇧 United Kingdom

Aptiva Celiac Disease IgA Reagent

FDA registration

INOVA DIAGNOSTICS, INC.·3 products·🇺🇸 United States

Aptima CV/TV Assay

FDA registration

Hologic, Inc.·3 products·🇺🇸 United States

ELITe MGB Software

FDA registration

ELITechGroup MDX LLC.·3 products·🇺🇸 United States

T2 Biothreat Panel

FDA registration

T2 BIOSYSTEMS, INC.·3 products·🇺🇸 United States

INFINITI FACTOR II-V Assay

FDA registration

AUTOGENOMICS, INCORPORATED·3 products·🇺🇸 United States

T2Biothreat® QCheck Negative Kit

FDA UDI

T2 BIOSYSTEMS, INC.·M70885113983·Negative quality control for T2Biothreat Panel

Aptima®

FDA UDI

Hologic, Inc.·15420045512054·Aptima® BV Assay Controls Kit.

Aptima®

FDA UDI

Hologic, Inc.·15420045512047·Aptima® BV Assay Calibrator.

Aptima®

FDA UDI

Hologic, Inc.·15420045512030·Aptima® BV assay, 100 test, box 2 of 2 (15°C to...

T2Biothreat® Reagent Trays

FDA UDI

T2 BIOSYSTEMS, INC.·M70880113943·The T2Biothreat Panel component that contains t...