FDA Registration
Active
🇬🇧 United Kingdom
BOND Ready-to-Use Primary Antibody Progesterone Receptor (16)
Reg #: 3004859032
·
FEI: 3004859032
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- LEICA BIOSYSTEMS NEWCASTLE LTD
- Registration Number
- 3004859032
- FEI Number
- 3004859032
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- BALLIOL BUSINESS PARK WEST, BENTON LANE
- City
- NEWCASTLE UPON TYNE
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K193393
Owner / Operator
- Firm Name
- Leica Biosystems, division of Leica Microsystems, Inc.
- Operator Number
- 10054155
- Address
- 21440 W. Lake Cook Road, Floor 5
- City
- Deer Park
- State
- IL
- Postal Code
- 60010
- Country
- US
- Correspondent
- Adam Blunier
US Agent
- Business Name
- Leica Biosystems, division of Leica Microsystems, Inc.
- Contact Name
- Adam Blunier
- Address
- 21440 W. Lake Cook Road, Floor 5
- City
- Deer Park
- State
- IL
- ZIP
- 60010
- Country
- US
- [email protected]
- Phone
- 630 6340069 ext. 3462
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Immunohistochemistry Assay, Antibody, Progesterone Receptor | MXZ | Class 2 | Hematology | No | 2020-03-19 |
Proprietary Names
BOND Ready-to-Use Primary Antibody Progesterone Receptor (16)
Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format)
Establishment Types
Manufacture Medical Device