FDA Registration
Active
🇺🇸 United States
ADVIA Centaur Anti-HBe (aHBe)
Reg #: 1219913
·
FEI: 1219913
·
Expires 2025
Products
1
Proprietary Names
5
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 |
|---|---|---|---|---|---|
| Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | LOM | Class 3 | Unknown | No | 2015-05-06 |
Proprietary Names
ADVIA Centaur Anti-HBe (aHBe)
ADVIA CENTAUR Anti-HBe QC (aHBe QC)
ADVIA CENTAUR HBsAgII (HBsII)
ADVIA Centaur Anti-HBe2 (aHBe2)
ADVIA Centaur Anti-HBe2 QC (aHBe2 QC)
Establishment Types
Manufacture Device in the United States for Export Only