Lipase NG B82715
Lipase NG B82715 is a Class I device made by Sentinel Ch. Srl, listed in FDA GUDID since 7 Aug 2016 (UDI-DI 08058056681782), 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 | Number08058056681782 | Date7 Aug 2016 | StatusListed |
Official records
- AccessGUDID record 08058056681782
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Lipase NG
- Generic name
- Lipase IVD, reagent
- Model / Ref / Catalog
- B82715
- Primary DI / UDI-DI
- 08058056681782
- FDA product code
- CHI
- GMDN term
- Lipase IVD, reagent
- Device class
- Class I
- Regulation number
- 862.1465
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 150 Milliliter
Similar devices
Other devices filed under FDA product code CHI (Lipase-Esterase, Enzymatic, Photometric, Lipase).
- ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY by Nuclear Diagnostics, Inc.
- ABX PENTRA LIPASE CP 1220001631 by Horiba Abx
- SENTINEL LIPASE LIQUID MODEL 17.401B by Equal Diagnostics, Inc.
- KODAK EKTACHEM DT SLIDES (LIPA) by EASTMAN KODAK COMPANY
- WAKO AUTOKIT LIPASE-COLOR by Wako Chemicals USA, Inc.
- Dimension® Flex® reagent cartridge LIPL 10460277 DF56 by Siemens Healthcare Diagnostics Inc.
- Alinity 04U0020 by ABBOTT IRELAND
- Alinity 04U0001 by ABBOTT IRELAND
- WAKO(TM) AUTOKIT LIPASE by Wako Chemicals USA, Inc.
- LIPASE UV [TOYO] by Advocacy International, Ltd.