MyHealthChecked Phlebotomy Sample Collection Kit (butterfly needle)– Gold & Lavender Tube (Single Test)

Basic UDI-DI

EU MDR · Eu Md Class 2a ·1 device

Reagents And Transportation Supplies, Sodium Citrate Blood Specimen Collection Tube

FDA classification

FDA Not Classified ·Reagents And Transportation Supplies, Sodium Citrate Blood Specimen Collection Tube

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

FDA Pre-Market Approval

FDA Class 3 ·RESOLUTION ctDx FIRST

InterCare Vascular Diagnostic Center

FDA UDI

INTERCARE DX, INC.·B2623000·The InterCare Vascular Diagnostic Center (Model...

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA classification

FDA Class 3 ·Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

Access SARS-CoV-2 IgG

FDA UDI

Beckman Coulter, Inc.·15099590738648·The Access SARS-CoV-2 IgG assay is a paramagnet...

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software

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

FDA Pre-Market Approval

FDA Class 3 ·Guardant360 CDx

Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptide) EIA

FDA UDI

AXIS-SHIELD DIAGNOSTICS LIMITED·05055845400497·The Axis-Shield Anti-CCP test is a semi-quantit...

Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptide) EIA

FDA UDI

AXIS-SHIELD DIAGNOSTICS LIMITED·05055845400008·The Axis-Shield Anti-CCP test is a semi-quantit...

Elana Surgical Kit HUD

FDA UDI

Elana B.V.·M602801H00013·Elana Surical Kit HUD The Elana Sutrgical Kit H...

Spiro PD

FDA UDI

PMD HEALTHCARE, INC.·00857845006007·The Spiro PD personal spirometer is a hand held...

Access SARS-CoV-2 IgM

FDA UDI

Beckman Coulter, Inc.·15099590738617·The Access SARS-CoV-2 IgM is a paramagnetic par...

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab

Thermocycler, Generic

FDA classification

FDA Class 1 ·Thermocycler, Generic

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

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne Liquid CDx

Strep-A-Chek(TM) Kit

FDA UDI

E-Y Laboratories, Inc.·00863251000201·Strep-A-Chek™ Kit is intended for use in the de...

Strep-A-Chek(TM) Strips (100 pcs)

FDA UDI

E-Y Laboratories, Inc.·00863251000225·Strep-A-Chek™ Reagent Strips are paper strips i...