416 results · 16ms · Sources: EU EUDAMED, US FDA

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FLUOREX DTA-400A

FDA 510(k)
FDA Class 2 ·Radiology

Tester, Pacemaker Electrode Function

FDA classification
FDA Class 2 ·Tester, Pacemaker Electrode Function

BARD BTA TRAK TEST

FDA 510(k)
FDA Class 2 ·Immunology

Blood Transfer Accessory (BTA)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

BARD AND BTA TEST

FDA 510(k)
FDA Class 2 ·Immunology

ATA HCM MONOPLACE HYPERBARIC SYSTEM

FDA 510(k)
FDA Class 2 ·Anesthesiology

BTA STAT TEST PRESCRIPTION HOME USE

FDA 510(k)
FDA Class 2 ·Immunology

T/K (ATA/AMA) UNIVERSAL BIOPAK

FDA 510(k)
FDA Class 2 ·Immunology

PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML.

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

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