Stat Profile Prime ES Comp Plus
by Nova Biomedical Corporation 8 variants
Stat Profile Prime ES Comp Plus (62350) is a Class II device made by Nova Biomedical Corporation, listed in FDA GUDID since 3 Feb 2020 (UDI-DI 00385480623506), 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 | Number00385480623506 | Date3 Feb 2020 | StatusListed |
Official records
- AccessGUDID record 00385480623506
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Stat Profile
- Generic name
- Multichannel clinical chemistry analyser IVD, point-of-care, line-powered
- Model / Ref / Catalog
- Prime ES Comp Plus, 62350
- Primary DI / UDI-DI
- 00385480623506
- FDA product code
- CHL
- GMDN term
- Multichannel clinical chemistry analyser IVD, point-of-care, line-powered
- Device class
- Class II
- Regulation number
- 862.1120
- GUDID distribution status
- In Commercial Distribution
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