FDA Registration
Active
🇺🇸 United States
Haemonetics Corporation
Reg #: 3019849102
·
FEI: 3019849102
·
Expires 2026
Products
7
Proprietary Names
11
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- Haemonetics Corporation
- Registration Number
- 3019849102
- FEI Number
- 3019849102
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1300 Clifford Ball Drive
- City
- Clinton
- State
- PA
- ZIP
- 15026
- Country
- US
Regulatory Submissions
- 510(k) Number
- K062604
Owner / Operator
- Firm Name
- Haemonetics Corporation
- Operator Number
- 1219343
- Address
- 125 Summer St
- City
- Boston
- State
- MA
- Postal Code
- 02110
- Country
- US
- Correspondent
- Julie A Ryan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Activated Whole Blood Clotting Time | JBP | Class 2 | Hematology | No | 2007-12-11 |
| Separator, Automated, Blood Cell, Diagnostic | GKT | Class 2 | Hematology | No | 2018-08-22 |
| System, Multipurpose For In Vitro Coagulation Studies | JPA | Class 2 | Hematology | No | 2025-06-04 |
| Plasma, Coagulation Control | GGN | Class 2 | Hematology | No | 2018-09-20 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2025-05-13 |
| Container, Empty, For Collection & Processing Of Blood & Blood Components | KSR | Class 2 | Hematology | No | 2009-10-20 |
| System, Automated Platelet Aggregation | JOZ | Class 2 | Hematology | No | 2015-03-13 |
Proprietary Names
RapidTeg TEG-ACT Test
PCS 300, NexSys PCS
TEG 6s
TEG 6s QC
TEG 5000 Analyzer
Antiplatelet Reagent
PCS2, PCS 300, NexSys PCS
TEG 5000
NexSys PCS, Express Plus
TEG 6s Global Hemostasis - HN Cartridge
PlateletMapping
Establishment Types
Manufacture Medical Device
Manufacture Device in the United States for Export Only