FDA Registration
Active
🇺🇸 United States
Atellica IM B.R.A.H.M.S PCT MCM (PCT MCM)
Reg #: 1219913
·
FEI: 1219913
·
Expires 2025
Products
1
Proprietary Names
91
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Siemens Healthcare Diagnostics Inc.
- Registration Number
- 1219913
- FEI Number
- 1219913
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 333 Coney Street
- City
- E Walpole
- State
- MA
- ZIP
- 02032
- Country
- US
Owner / Operator
- Firm Name
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- Operator Number
- 9096044
- Address
- Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue
- City
- Tarrytown
- State
- NY
- Postal Code
- 10591
- Country
- US
- Correspondent
- Mary Seeger
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2018-07-18 |
Proprietary Names
Atellica IM B.R.A.H.M.S PCT MCM (PCT MCM)
ADVIA Centaur Active-B12 Master Curve Material (AB12 MCM)
ADVIA Centaur Calcitonin MCM (CALCT MCM)
Atellica IM Active-B12 QC (AB12 QC)
Atellica IM EPO MCM (EPO MCM)
ADVIA Centaur EPO MCM (EPO MCM)
ADVIA Centaur Active-B12 Quality Control (AB12 QC)
Atellica IM High Sensitivity Troponin I Master Curve Material (TnIH MCM)
Atellica IM PSA MCM (PSA MCM)
Atellica IM B.R.A.H.M.S PCT QC (PCT QC)
Atellica IM Ferritin MCM (FER MCM)
Atellica IM Active-B12 Master Curve Material (AB12 MCM)
Atellica IM Calcitonin MCM (CALCT MCM)
ADVIA Centaur EPO QC (EPO QC)
ADVIA Centaur Androstenedione (ANDRO) Master Curve Material (ANDRO MCM)
Atellica IM EPO Controls (EPO QC)
Atellica IM Androstenedione MCM (ANDRO MCM)
ADVIA Centaur Enhanced Liver Fibrosis Master Curve Material (ELF MCM)
Atellica IM B-type Natriuretic Peptide Master Curve Material (BNP MCM)
Atellica IM Tg Master Curve Material (Tg MCM)
ADVIA Centaur B-type Natriuretic Peptide Master Curve Material (BNP MCM)
ADVIA Centaur Insulin Master Curve Material (IRI MCM)
ADVIA Centaur Total Thyroxine Master Curve Material (T4 MCM)
ADVIA Centaur Troponin I Ultra Master Curve Material (TnI-Ultra MCM)
Atellica IM Anti-HBe2 Quality Control (aHBe2 QC)
ADVIA Centaur Enhanced Liver Fibrosis Quality Control (ELF QC)
ADVIA Centaur aCCP QC (aCCP QC)
ADVIA Centaur aCCP Master Curve Material (aCCP MCM)
Atellica IM Herpes-2 IgG Quality Control (HSV2 QC)
Atellica IM Cortisol Master Curve Material (Cor MCM)
ADVIA Centaur Ferritin Master Curve Material (FER MCM)
ADVIA Centaur Prolactin Master Curve Material (PRL MCM)
ADVIA Centaur Free Thyroxine Master Curve Material (FT4 MCM)
ADVIA Centaur Herpes-2 IgG Quality Control (HSV2 QC)
ADVIA Centaur C-peptide Master Curve Material (CpS MCM)
ADVIA Centaur Digoxin Master Curve Material (Dig MCM)
Atellica IM NT-proBNP Master Curve Material(PBNP MCM)
ADVIA Centaur Herpes-1 IgG Quality Control (HSV1 QC)
Atellica IM Herpes-1 IgG Quality Control (HSV1 QC)
Atellica IM Luteinizing Hormone Master Curve Material (LH MCM)
Atellica IM HER-2/neu Master Curve Material (H2n MCM)
ADVIA Centaur aTgII Master Curve Material (aTgII MCM)
ADVIA Centaur Prostate-Specific Antigen Master Curve Material (PSA MCM)
Atellica IM Anti-Thyroid Peroxidase Master Curve Material (aTPO MCM)
Atellica IM Alpha Fetoprotein Master Curve Material (AFP MCM)
Atellica IM CA 19-9 Master Curve Material (CA 19-9 MCM)
ADVIA Centaur Homocysteine Master Curve Material (HCY MCM)
ADVIA Centaur Anti-Hepatitis B surface Antigen 2 Master Curve Material (aHBs2 MCM)
ADVIA Centaur PIIINP MCM (PIIINP MCM)
ADVIA Centaur Total hCG Master Curve Material (ThCG MCM)
Atellica IM Creatine Kinase MB Master Curve Material (CKMB MCM)
Atellica IM Carcinoembryonic Antigen Master Curve Material (CEA MCM)
Atellica IM Anti-Thyroglobulin Master Curve Material (aTG MCM)
Atellica IM TSH3-Ultra II Master Curve Material (TSH3ULII MCM)
Atellica IM Anti-Hepatitis B surface Antigen 2 Master Curve Material (aHBs2 MCM)
ADVIA Centaur HER-2/neu Master Curve Material (H2n MCM)
IMMULITE 2000 Anti-CCP Calibration Verification Material (CCP CVM)
ADVIA Centaur Vitamin B12 Master Curve Material (VB12 MCM)
ADVIA Centaur CEA Master Curve Material (CEA MCM)
Atellica IM aTPOII Master Curve Material (aTPOII MCM)
Atellica IM Enhanced Liver Fibrosis Quality Control (ELF QC)
Atellica IM Cyclosporine Master Curve Material (CsA MCM)
ADVIA Centaur Folate Master Curve Material (FOL MCM)
ADVIA Centaur Myoglobin Master Curve Material (MYO MCM)
Atellica IM Thyroid Stimulating Hormone 3-Ultra Master Curve Material (TSH3-UL MCM)
ADVIA Centaur Quantitative HBsAg Master Curve Material (QHBs MCM)
ADVIA Centaur Alpha Fetoprotein Master Curve Material (AFP MCM)
ADVIA Centaur aTPOII Quality Control (aTPOII QC)
Atellica IM PBNPII Master Curve Material (PBNPII MCM)
Atellica IM Enhanced Liver Fibrosis Master Curve Material (ELF MCM)
Atellica IM Total hCG MCM (ThCG MCM)
Atellica IM CA 125II Master Curve Material (CA 125II MCM)
ADVIA Centaur NT-proBNP (PBNP) Master Curve Material
Atellica IM Complexed Prostate-Specific Antigen Master Curve Material (cPSA MCM)
Atellica IM Free Triiodothyronine Master Curve Material (FT3 MCM)
ADVIA Centaur PBNPII Master Curve Material (PBNPII MCM)
ADVIA Centaur Cyclosporine Master Curve Material (CsA MCM)
ADVIA Centaur DHEA-SO4 Master Curve Material (DHEAS MCM) SET
Atellica IM Myoglobin Master Curve Material (MYO MCM)
Atellica IM aTgII Master Curve Material (aTgII MCM)
IMMULITE 2000 TSI Calibration Verification Material (TSI CVM)
Atellica IM CA 15-3 Master Curve Material (CA 15-3 MCM)
Atellica IM Vitamin B12 Master Curve Material (VB12 MCM)
Atellica IM Homocysteine Master Curve Material (HCY MCM)
Atellica IM aTPOII Quality Control (aTPOII QC)
Atellica IM BR 27.29 Master Curve Material (BR MCM)
Atellica IM DHEA-SO4 Master Curve Material (DHEAS MCM)
ADVIA Centaur Free Triiodothyronine Master Curve Material (FT3 MCM)
Atellica IM Folate Master Curve Material (FOL MCM)
ADVIA Centaur aTPOII Master Curve Material (aTPOII MCM)
Atellica IM DHEAS2 Master Curve Material (DHEAS2 MCM)
Establishment Types
Manufacture Medical Device