FDA Registration
Active
🇺🇸 United States
ACD-A
Reg #: 1216032
·
FEI: 1216032
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Citra Labs LLC
- Registration Number
- 1216032
- FEI Number
- 1216032
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 55 Messina Dr
- City
- Braintree
- State
- MA
- ZIP
- 02184
- Country
- US
Regulatory Submissions
- 510(k) Number
- BK950060
Owner / Operator
- Firm Name
- Biomet, Inc.
- Operator Number
- 1825034
- Address
- 56 East Bell Dr., PO Box 587
- City
- Warsaw
- State
- IN
- Postal Code
- 46582
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Set, Transfer (Blood/Plasma) | KSB | Class 2 | Hematology | No | 2016-12-09 |
Proprietary Names
ACD-A
Rejuvesol
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198