FDA Registration
Active
🇺🇸 United States
AMERICAN RED CROSS DIAGNOSTIC MANUFACTURING DIVISI
Reg #: 1177732
·
FEI: 1177732
·
Expires 2026
Products
4
Proprietary Names
6
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- AMERICAN RED CROSS DIAGNOSTIC MANUFACTURING DIVISI
- Registration Number
- 1177732
- FEI Number
- 1177732
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9319 Gaither Rd
- City
- GAITHERSBURG
- State
- MD
- ZIP
- 20877
- Country
- US
Regulatory Submissions
- 510(k) Number
- BK090021
Owner / Operator
- Firm Name
- AMERICAN NATIONAL RED CROSS HEADQUARTERS
- Operator Number
- 9024647
- Address
- 431 18th Street NW, --
- City
- Washington
- State
- DC
- Postal Code
- 20006
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Diluent, Blood Cell | GIF | Class 1 | Hematology | No | 1996-12-31 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2024-12-27 |
| Kit, Quality Control For Blood Banking Reagents | KSF | Class 2 | Hematology | No | 2009-10-26 |
| Media, Potentiating For In Vitro Diagnostic Use | KSG | Class 2 | Hematology | No | 2018-08-06 |
Proprietary Names
Red Cell Storage Solution (RCSS)
0.2M Dithiothreitol (DTT)
Control Cells
Polyethylene Glycol (PEG)
Low Ionic Strength Solution (LISS)
DailyChek QC Kit
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)