696 results · 7ms · Sources: EU EUDAMED, US FDA

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PECOR 8.5 FRENCH IAB ON A DATASCOPE

FDA 510(k)
FDA Class 2 ·Cardiovascular

DIRECT BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU.

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

TOTAL BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU.

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

TOTAL BILIRUBIN PROCEDURE RUN ON A DEMAND INSTRU.

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Computer Assisted Hair Harvesting System

FDA classification
FDA Class 2 ·Computer Assisted Hair Harvesting System

NOVA 5 NA/K/C1 ALALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

NOVA 4 NA/K/C1/TCO2/LI ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Dna And Rna Oncology Controls

FDA classification
FDA Class 2 ·Dna And Rna Oncology Controls

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 2 ·COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM AND COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 2 ·Abbott RealTime HBV Assay

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN CMV TEST

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·Cobas AmpliPrep/Cobas TaqMan CMV Test

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 2 ·Alinity m HBV

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 2 ·COBAS TaqMan HBV Test for use with the High Pure System and COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 2 ·ROCHE COBAS TAQMAN HBV TESTS

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 2 ·cobas HBV

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 2 ·COBAS® AmpliPrep® / COBAS® TaqMan® HBV Test, v2.0

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·cobas CMV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·Cobas AmpliPrep/Cobas TaqMan CMV Test

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 2 ·cobas HBV