LeucoScreen
by Fertipro NV
LeucoScreen, a medical device (FDA Class I; FDA product code LED, Stains, Chemical Solution) made by Fertipro NV, was listed in FDA GUDID on 22 Aug 2018 (UDI-DI 54119670001970); the registry lists it as not in commercial distribution (GUDID) as of 21 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 | Number54119670001970 | Date22 Aug 2018 | StatusListed |
Official records
- AccessGUDID record 54119670001970
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Generic name
- Myeloperoxidase (MPO) IVD, kit, enzyme immunohistochemistry
- Model / reference
- LEUCO
- Primary DI / UDI-DI
- 54119670001970
- FDA product code
- LED
- GMDN term
- Myeloperoxidase (MPO) IVD, kit, enzyme immunohistochemistry
- Device class
- Class I
- Regulation number
- 864.1850
- GUDID distribution status
- Not in Commercial Distribution
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