Siemens Healthcare Diagnostics Products Ltd.

Manufacturer

3 Importers

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE/IMMULITE 1000, IMMULITE 2000 HBSAG/HBSAG CONFIMATORY

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC IGM

IMMULITE® Systems CONTROL Calcitonin

FDA UDI

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD·00630414953120·IMMULITE® Systems CONTROL Calcitonin

IMMULITE®2000 Systems 3gAllergy™ Pigeon Droppings

FDA UDI

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD·00630414996578·Pigeon Droppings -Specific IgE - IMMULITE - RGT

IMMULITE®2000 Systems 3gAllergy™ Haddock

FDA UDI

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD·00630414978604·Haddock-Specific IgE - IMMULITE - RGT

IMMULITE®/IMMULITE® 1000 Systems GAS Gastrin

FDA UDI

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD·00630414964034·Gastrin - IMMULITE - RGT - 100 Tests

IMMULITE® Systems CRP CONTROL C-Reactive Protein

FDA UDI

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD·00630414953144·IMMULITE® Systems CRP CONTROL C-Reactive Protein

IMMULITE® 2000 Systems PRG Progesterone

FDA UDI

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD·00630414961989·Progesterone - IMMULITE - RGT - 600 Tests

IMMULITE® 2000 Systems FER Ferritin

FDA UDI

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD·00630414961460·Ferritin - IMMULITE - RGT - 200 Tests

IMMULITE®/IMMULITE® 1000 Systems BRM BR-MA (CA15-3)

FDA UDI

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD·00630414963655·CA 15-3 - IMMULITE - RGT - 100 Tests

IMMULITE®2000 Systems 3gAllergy™ Bayberry/Sweet Gale

FDA UDI

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD·00630414978932·Bayberry/Sweet Gale-Specific IgE - IMMULITE - RGT

IMMULITE®2000 Systems 3gAllergy™ Rat Epithelium

FDA UDI

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD·00630414959788·Rat Epithelium -Specific IgE - IMMULITE - RGT

IMMULITE®2000 Systems 3gAllergy™ Egg Pineapple

FDA UDI

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD·00630414973319·Pineapple-Specific IgE - IMMULITE - RGT

IMMULITE®2000 Systems 3gAllergy™ nDer f 1

FDA UDI

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD·00630414970639·Dermatophagoides farinae-Specific IgE - IMMULIT...

IMMULITE®2000 Systems 3gAllergy™ Food Panel 2

FDA UDI

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD·00630414960401·Food Panel 2 - IMMULITE - RGT - 40 test

IMMULITE®2000 Systems 3gAllergy™ Grass Panel 3

FDA UDI

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD·00630414960623·Grass Panel 3 - IMMULITE - RGT - 40 test

IMMULITE® Systems BMG CONTROL Beta-2 Microglobulin

FDA UDI

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD·00630414952956·B2-MICROGLOBULIN - IMMULITE - CTL - 3x1mL