Signify® 01P52-25
Signify® 01P52-25 is a Class II device made by Alere San Diego, Inc., listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10815845020062), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10815845020062 | Date24 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 10815845020062
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Signify®
- Generic name
- Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical
- Model / reference
- 01P52-25
- Primary DI / UDI-DI
- 10815845020062
- FDA product code
- KTN
- GMDN term
- Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical
- Device class
- Class II
- Regulation number
- 866.5640
- GUDID distribution status
- In Commercial Distribution
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