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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATOR

Immunohistochemistry Assay, Antibody, Met

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Met

Immunohistochemistry Assay, Antibody, Claudin 18

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Claudin 18

Immunohistochemistry Assay, Antibody, Folr1

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Folr1

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

Immunohistochemistry Assay, Antibody, Ki-67

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Ki-67

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA classification

FDA Class 3 ·Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4

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

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

Apparatus, Electronanesthesia

FDA classification

FDA Class 3 ·Apparatus, Electronanesthesia

Lens, Intraocular, Toric Optics

FDA classification

FDA Class 3 ·Lens, Intraocular, Toric Optics

Ophthalmic Sealant

FDA classification

FDA Class 3 ·Ophthalmic Sealant

Prosthesis, Hip, Constrained, Metal

FDA classification

FDA Class 3 ·Prosthesis, Hip, Constrained, Metal

System, Laser, Photodynamic Therapy

FDA classification

FDA Class 3 ·System, Laser, Photodynamic Therapy

Metal Cemented Constrained Femorotibial Knee Prosthesis

FDA classification

FDA Class 3 ·Metal Cemented Constrained Femorotibial Knee Prosthesis

Catheter, Percutaneous, Long Term, Intraspinal

FDA classification

FDA Class 3 ·Catheter, Percutaneous, Long Term, Intraspinal

Materials, Repair Or Replacement, Pacemaker

FDA classification

FDA Class 3 ·Materials, Repair Or Replacement, Pacemaker

Cooler, Prostatic

FDA classification

FDA Class 3 ·Cooler, Prostatic