GeneSTAT

FDA UDI

DXNA LLC·A91004001·Automated PCR analyzer

GeneSTAT.MDx Coccidioides Assay

FDA 510(k)

FDA Class 2 ·Microbiology

Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens

FDA classification

FDA Class 2 ·Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens

EL1950 STRATIFY JCV® DxSelect™

FDA registration

DiaSorin Molecular LLC·1 product·🇺🇸 United States

Rickettsia Spp. Nucleic Acid Based Detection Assay

FDA registration

CENTERS FOR DISEASE CONTROL AND PREVENTION·1 product·🇺🇸 United States

Variola virus Real-time PCR Assay

FDA registration

CENTERS FOR DISEASE CONTROL AND PREVENTION·1 product·🇺🇸 United States

ID-FISH Plasmodium faliciparum and P. vivax Combo Test Kit

FDA registration

ID-FISH TECHNOLOGY, INC·1 product·🇺🇸 United States

ImmunoWELL anti-JCV IgG Test

FDA registration

GENBIO·1 product·🇺🇸 United States

ACCUPROBE®

FDA UDI

Hologic, Inc.·15420045506145·AccuProbe® Mycobacterium gordonae.

ACCUPROBE®

FDA UDI

Hologic, Inc.·15420045506138·AccuProbe® Mycobacterium avium Complex.

ACCUPROBE

FDA UDI

Hologic, Inc.·15420045506091·

ACCUPROBE®

FDA UDI

Hologic, Inc.·15420045506152·AccuProbe® Mycobacterium kansasii.

ACCUPROBE®

FDA UDI

Hologic, Inc.·15420045506121·AccuProbe® Mycobacterium intracellulare.

ACCUPROBE®

FDA UDI

Hologic, Inc.·15420045506114·AccuProbe® Mycobacterium avium.

ACCUPROBE®

FDA UDI

Hologic, Inc.·15420045506169·AccuProbe® Mycobacterium tuberculosis Complex.

STRATIFY JCV™ DXSELECT™

FDA UDI

DIASORIN MOLECULAR LLC·20816101022254·

STRATIFY JCV™ DXSELECT™

FDA UDI

DIASORIN MOLECULAR LLC·20816101022261·

ACCUPROBE®

FDA UDI

Hologic, Inc.·15420045506459·Detection Reagent Kit.

STRATIFY JCV(TM) ANTIBODY

FDA 510(k)

FDA Class 2 ·Microbiology

STRATIFY JCV DXSELECT

FDA 510(k)

FDA Class 2 ·Microbiology