FDA Registration
Active
🇺🇸 United States
ADVIA Centaur Luteinizing Hormone (LH)
Reg #: 2432235
·
FEI: 2432235
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Siemens Healthcare Diagnostics Inc.
- Registration Number
- 2432235
- FEI Number
- 2432235
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 511 Benedict Ave
- City
- Tarrytown
- State
- NY
- ZIP
- 10591
- Country
- US
Regulatory Submissions
- 510(k) Number
- K910198
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 |
|---|---|---|---|---|---|
| Radioimmunoassay, Luteinizing Hormone | CEP | Class 1 | Clinical Chemistry | No | 2007-12-27 |
Proprietary Names
ADVIA Centaur Luteinizing Hormone (LH)
Atellica IM Luteinizing Hormone (LH)
ADVIA Centaur Luteinizing Hormone Master Curve Material (LH MCM)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility