PDT, Inc.

System producer

🇺🇸 United States

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

FDA classification

FDA Class 1 ·Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control

MDT-Medical Data Transfer s.r.o.

Importer

🇨🇿 Czechia

Ldt, Approved By Nys Clep

FDA classification

FDA Not Classified ·Ldt, Approved By Nys Clep

Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

FDA classification

FDA Not Classified ·Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

CHIRASTAR KDT, s.r.o.

System producer

🇨🇿 Czechia

QMT-Tech ab

System producer

🇸🇪 Sweden

FIBER GRAPHICS EXTENSION RECEIVER (68395)

FDA registration

PENTAX of America, Inc.·1 product·🇺🇸 United States

Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

FDA classification

FDA Not Classified ·Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

MiPlant

Importer

🇧🇬 Bulgaria·5 Manufacturers

Premier Medical Ltd.

Importer

🇮🇪 Ireland·6 Manufacturers

Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

FDA classification

FDA Not Classified ·Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

Ldt, Unmet Need Within An Integrated Healthcare System

FDA classification

FDA Not Classified ·Ldt, Unmet Need Within An Integrated Healthcare System

FI20/07011

Certificate

MDD Annex II (excluding section 4)·QT Medical, Inc.·SGS FIMKO OY·1 Basic UDI-DI

Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule

FDA classification

FDA Not Classified ·Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule

Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring

FDA classification

FDA Not Classified ·Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring

Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd

FDA classification

FDA Not Classified ·Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd

Dimension GGT Flex

FDA registration

SIEMENS HEALTHCARE DIAGNOSTICS INC.·11 products·🇺🇸 United States

COBAS INTEGRA REAGENT CASSETTES

FDA registration

ROCHE DIAGNOSTICS GMBH·13 products·🇩🇪 Germany