10,000 results · 32ms · Sources: EU EUDAMED, US FDA

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM/COBAS AMPLIPREP/COBAS TAQMAN HBV TEST

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PRESSURE SYSTEM, COBAS AMPLIPREP/COBAS TAQMAN HBV TEST

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·COBAS HPV TEST

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·cobas HPV Test, 240 Tests, cobas HPV Test, 960 Tests

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas EGFR Mutation Test and cobas EGFR Mutation Test v2

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·COBAS EGFR Mutation Test and cobas EGFR Mutation Test, v2.0

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test, v2.0

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas EGFR Mutation Test and cobas EGFR Mutation Test v2

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·COBAS® AmpliPrep, COBAS® TaqMan® HBV Test, v2.0

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas EGFR Mutation Test and cobas EGFR Mutation Test v2

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·cobas HPV for use on the cobas 6800/8800 Systems

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas EGFR Mutation Test and cobas EGFR Mutation Test v2

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas EGFR Mutation Test and cobas EGFR Mutation Test v2

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·Cobas EGFR Mutation Test and Cobas EGFR v2 Mutation Test

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·Cobas EGFR Mutation Test and Cobas EGFR Mutation Test v2

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·COBAS HPV TEST, 240 TESTS; COBAS HPV TEST, 960 TESTS

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas EGFR Mutation Test and cobas EGFR Mutation Test v2

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas EGFR Mutation Test and cobas EGFR Mutation Test v2

BLOOD GAS EXPERSYSTEM 8700

FDA 510(k)
FDA Class 3 ·Unknown

INIVOX ELECTRODE/CATHETER SYS

FDA 510(k)
FDA Class 3 ·Unknown