ThromboTek PSe

FDA UDI

R 2 DIAGNOSTICS, INC.·00859394006095·Protein S Kit 80-160 DET

LupoTek Correctin VL

FDA UDI

R 2 DIAGNOSTICS, INC.·10859394006115·Venom Confirmatory test for LA 10 x 1 ml

Phosphoplastin RL

FDA UDI

R 2 DIAGNOSTICS, INC.·10859394006023·PT reagent 10 x 5 ml

PlasmaCon LA

FDA UDI

R 2 DIAGNOSTICS, INC.·10859394006139·Positive control for LA 10 x 1 ml

Phospholin ES w/ Calcium Chloride

FDA UDI

R 2 DIAGNOSTICS, INC.·10859394006016·APTT reagent 5 x 10 ml with 5 Calcium Chloride

PlasmaRef ARN

FDA UDI

R 2 DIAGNOSTICS, INC.·10859394006177·Assayed Reference Plasma 10 x 1 ml

Phospholin ES w/Calcium

FDA UDI

R 2 DIAGNOSTICS, INC.·10859394006238·APTT reagent 5 x 5 ml

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne Liquid CDx (F1 Liquid CDx)

SUNGO Europe B.V.

Authorized representative

🇳🇱 Netherlands·1571 Manufacturers·20390 Devices

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne Liquid CDx (F1 Liquid CDx)

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·ALERE NMP22 URINE COLLECTION KIT

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·RESOLUTION ctDx FIRST

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·Guardant360 CDx

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne Liquid CDx

Medical Technology Promedt Consulting GmbH

Authorized representative

🇩🇪 Germany·194 Manufacturers·10009 Devices

Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

FDA classification

FDA Class 2 ·Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

mdi Europa GmbH

Authorized representative

🇩🇪 Germany·132 Manufacturers·4741 Devices

Complement 4d (C4d) And Complement Receptor 1 (Cr1)

FDA classification

FDA Class 2 ·Complement 4d (C4d) And Complement Receptor 1 (Cr1)

Kingsmead Service B.V.

Authorized representative

🇳🇱 Netherlands·243 Manufacturers·2698 Devices

Emergo Europe B.V.

Authorized representative

🇳🇱 Netherlands·900 Manufacturers·22100 Devices