FDA Registration
Active
🇺🇸 United States
Revvity Health Sciences, Inc.
Reg #: 3007145015
·
FEI: 3007145015
·
Expires 2026
Products
3
Proprietary Names
4
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- Revvity Health Sciences, Inc.
- Registration Number
- 3007145015
- FEI Number
- 3007145015
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 17 P&N Drive
- City
- Greenville
- State
- SC
- ZIP
- 29611
- Country
- US
Regulatory Submissions
- 510(k) Number
- K121864
Owner / Operator
- Firm Name
- Revvity, Inc.
- Operator Number
- 9912035
- Address
- 77 4th Avenue
- City
- Waltham
- State
- MA
- Postal Code
- 02451
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Newborn Screening Specimen Collection Paper | PJC | Class 2 | Clinical Chemistry | No | 2013-03-14 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2019-02-21 |
| Blood And Urine Collection Kit (Excludes Hiv Testing) | OIB | Class 1 | Pathology | No | 2021-11-18 |
Proprietary Names
Contract Manufactured Collection Device with Ahlstrom 226 filter paper.
Revvity 226 Sample Collection Device
Revvity GRNK1
Revvity Blood Collection Kit
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device