FDA Registration
Active
🇮🇪 Ireland
PerFix NC Kit (Lysing Reagent)
Reg #: 9680746
·
FEI: 1000206808
·
Expires 2025
Products
1
Proprietary Names
26
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Beckman Coulter Ireland Inc
- Registration Number
- 9680746
- FEI Number
- 1000206808
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- LISMEEHAN
- City
- O CALLAGHANS MILLS Clare
- Country
- IE
Owner / Operator
- Firm Name
- BECKMAN COULTER, INC.
- Operator Number
- 2050012
- Address
- 250 S. Kraemer Blvd, --
- City
- Brea
- State
- CA
- Postal Code
- 92821
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Products, Red-Cell Lysing Products | GGK | Class 1 | Hematology | No | 1977-12-14 |
Proprietary Names
PerFix NC Kit (Lysing Reagent)
IRIS BODY FLUIDS LYSING REAGENT
OptiLyse C : Lysing Solution
AQUIOS Lysing Reagent Kit
IntraPrep
VersaLyse : Lysing Solution
Fixative Solution (10X)
Lysing Solution (10X)
IOTest 3 Lyse
Reagent 2: Permeabilization
IOTest 3 Fixative
DxH 500 Series Lyse (PN B36846)
DxH Cell Lyse 1L & 5L
COULTER Rinsol Cleaning Agent
DxH ECO Cell Lyse (5L)
AcT 5diff Hgb Lyse
IMMUNOPREP REAGENT
Whole Blood Lysing Reagent
COULTER DxH Cell Lyse
AcT 5diff WBC Lyse
DxH Retic Pack
DxH diff Pack
AcT 5diff Fix
DxH ECO Cell Lyse (1L)
Access Red Blood Cell Folate Lysing Agent
Access Red Blood Cell Folate Lysing Agent (P/N: A14206 CA MFG)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)