FDA Registration
Active
🇺🇸 United States
ADVIA Centaur HIV Ag/Ab Combo Quality Control Kit (CHIV QC)
Reg #: 1219913
·
FEI: 1219913
·
Expires 2025
Products
1
Proprietary Names
4
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
Regulatory Submissions
- PMA Number
- BP140103
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, Hiv Detection | MZF | Class 2 | Microbiology | No | 2015-07-01 |
Proprietary Names
ADVIA Centaur HIV Ag/Ab Combo Quality Control Kit (CHIV QC)
Atellica IM HIV Ag/Ab Combo Quality Control Kit (CHIV QC)
Atellica IM HIV Ag/Ab Combo (CHIV)
ADVIA Centaur HIV Ag/Ab Combo (CHIV)
Establishment Types
Manufacture Medical Device