FDA Registration
Active
🇬🇧 United Kingdom
HD827-IVD- Mimix OncoSpan gDNA Reference Standard
Reg #: 3032324401
·
FEI: 3032324401
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Revvity Discovery Limited
- Registration Number
- 3032324401
- FEI Number
- 3032324401
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building 8100, Cambridge Research Park
- City
- Cambrige
- Country
- GB
Owner / Operator
- Firm Name
- Revvity, Inc.
- Operator Number
- 9912035
- Address
- 77 4th Avenue
- City
- Waltham
- State
- MA
- Postal Code
- 02451
- Country
- US
- Correspondent
- Daniel A Castellanos
US Agent
- Business Name
- REVVITY, INC.
- Contact Name
- Daniel Castellanos
- Address
- 77 4th Ave
- City
- Waltham
- State
- MA
- ZIP
- 02451
- Country
- US
- [email protected]
- Phone
- 408 8235561
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Multi-Analyte Controls Unassayed | OHQ | Class 1 | Clinical Chemistry | No | 2022-08-19 |
Proprietary Names
HD827-IVD- Mimix OncoSpan gDNA Reference Standard
DBS controls M2 (3255-0010)
DBS Controls LysoPC (3413-0010)
HD832-IVD- Mimix OncoSpan FFPE Reference Standard
HD829-IVD- Mimix Myeloid Cancer Panel gDNA Reference Standard
Establishment Types
Manufacture Medical Device