Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBS IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNDIAGNOSTICS PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·SURESCAN MRI IMPLANTABLE NEUROSTIMULATION SYSTEM

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY AND QAULITY CONTROL MATERIAL

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

FDA Pre-Market Approval

FDA Class 3 ·Oncomine Dx Target Test

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA PD-L1(SP142) Assay.

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·AXSYM HBSAG, HBSAG CONFIRMATORY, AND AXSYM HBSAG CONTROLS

Kit, Rna Detection, Human Papillomavirus

FDA classification

FDA Class 3 ·Kit, Rna Detection, Human Papillomavirus

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR ANTI-HBS2 ASSAY

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·therascreen PIK3CA RGQ PCR Kit

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck

Pump, Drug Administration, Closed Loop

FDA Pre-Market Approval

FDA Class 3 ·GENESA(R) SYSTEM

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·therascreen PIK3CA RGQ PCR Kit

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test

Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief

FDA classification

FDA Class 3 ·Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief

Ophthalmic Sealant

FDA classification

FDA Class 3 ·Ophthalmic Sealant

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

FDA Pre-Market Approval

FDA Class 3 ·myChoice CDx

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALK