ANSPACH MICROMAX SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

INVADER FACTOR II

FDA 510(k)

FDA Class 2 ·Hematology

cobas Factor II and Factor V Test

FDA 510(k)

FDA Class 2 ·Hematology

Xpert® FII & FV

FDA 510(k)

FDA Class 2 ·Hematology

FACTOR II (PROTHROMBIN) G20210A KIT

FDA 510(k)

FDA Class 2 ·Hematology

Xpert® FII & FV

FDA 510(k)

FDA Class 2 ·Hematology

Antithrombin Iii Quantitation

FDA classification

FDA Class 2 ·Antithrombin Iii Quantitation

System, Dialysate Delivery, Sealed

FDA classification

FDA Class 2 ·System, Dialysate Delivery, Sealed

Antigen, Antiserum, Control, Antithrombin Iii

FDA classification

FDA Class 2 ·Antigen, Antiserum, Control, Antithrombin Iii

Antithrombin Iii, Two Stage Clotting Time Assay

FDA classification

FDA Class 2 ·Antithrombin Iii, Two Stage Clotting Time Assay

Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody

FDA classification

FDA Class 2 ·Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)

Test, Factor Ii G20210a Mutations, Genomic Dna Pcr

FDA classification

FDA Class 2 ·Test, Factor Ii G20210a Mutations, Genomic Dna Pcr

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)

Sunlamp Products (Pre-Standard)

FDA classification

FDA Class 2 ·Sunlamp Products (Pre-Standard)

Reagents For Detection Of Norovirus Nucleic Acid

FDA classification

FDA Class 2 ·Reagents For Detection Of Norovirus Nucleic Acid

Goniometer With Electrodes

FDA classification

FDA Class 2 ·Goniometer With Electrodes

Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment

FDA classification

FDA Class 2 ·Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment

Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer

FDA classification

FDA Class 2 ·Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer