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

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Hepatitis B core IgM (aHBcM) assay; Atellica IM Hepatitis B core lgM Quality Control (aHBcM QC)

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

FDA Pre-Market Approval

FDA Class 3 ·Alinity i Anti-HBc lgM

Lumipulse G LH Immunoreaction Cartridges

FDA UDI

FUJIREBIO INC.·04987270235270·

DGH 1006 Corded Pachymeter Probe

FDA UDI

DGH TECHNOLOGY INC.·00857377006209·The DGH1006 is a straight corded probe containi...

DGH 2006 Corded Pachymeter Probe

FDA UDI

DGH TECHNOLOGY INC.·00857377006216·The DGH2006 is an angled corded probe containin...

SPOTCHEM™ EZ Analyzer

FDA UDI

ARKRAY USA, INC.·00015482183103·Dry Chemistry Analyzer IVD, semi-automated

SPOTCHEM™ II AST / GOT

FDA UDI

ARKRAY USA, INC.·00015482771102·Strip Description:  For the in vitro quantitati...

SPOTCHEM™ II ALP

FDA UDI

ARKRAY USA, INC.·00015482771157·Strip Description:  For the in vitro quantitati...

SPOTCHEM™ II LDH

FDA UDI

ARKRAY USA, INC.·00015482771201·Strip Description:  For the in vitro quantitati...

SPOTCHEM™ II Inorganic Phosphorous

FDA UDI

ARKRAY USA, INC.·00015482771188·Strip Description:  For the in vitro quantitati...

SPOTCHEM™ II Total Cholesterol

FDA UDI

ARKRAY USA, INC.·00015482771034·Strip Description:  For the in vitro quantitati...

SPOTCHEM™ II CPK

FDA UDI

ARKRAY USA, INC.·00015482771126·Strip Description:  For the in vitro quantitati...

SPOTCHEM™ II Total Bilirubin

FDA UDI

ARKRAY USA, INC.·00015482771065·Strip Description:  For the in vitro quantitati...

SPOTCHEM™ II Triglycerides

FDA UDI

ARKRAY USA, INC.·00015482771041·Strip Description:  For the in vitro quantitati...

SPOTCHEM™ II Fructosamine

FDA UDI

ARKRAY USA, INC.·00015482771171·Strip Description:  For the in vitro quantitati...

SPOTCHEM™ II Glucose

FDA UDI

ARKRAY USA, INC.·00015482771010·Strip Description:  For the in vitro quantitati...

SPOTCHEM™ II Basic Panel 1

FDA UDI

ARKRAY USA, INC.·00015482771263·Strip Description:  For the in vitro quantitati...

SPOTCHEM™ II Basic Panel 2

FDA UDI

ARKRAY USA, INC.·00015482771270·Strip Description:  For the in vitro quantitati...

SPOTCHEM™ II GGT

FDA UDI

ARKRAY USA, INC.·00015482771140·Strip Description:  For the in vitro quantitati...

SPOTCHEM™ II HDL-Cholesterol

FDA UDI

ARKRAY USA, INC.·00015482771225·Strip Description:  For the in vitro quantitati...