Nova 1/4/5/8/10/11/13
by Nova Biomedical Corporation
Nova 1/4/5/8/10/11/13 (12882) is a Class I device made by Nova Biomedical Corporation, listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00385480128827), 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 | Number00385480128827 | Date20 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00385480128827
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Nova
- Generic name
- Buffered sample diluent IVD, manual
- Model / Ref / Catalog
- 1/4/5/8/10/11/13, 12882
- Primary DI / UDI-DI
- 00385480128827
- FDA product code
- CFA, NDW, JGS, CHL, JFP, JPI, JFL, CGZ, CEM
- GMDN term
- Buffered sample diluent IVD, manual
- Device class
- Class I
- Regulation number
- 862.1495, 862.3560, 862.1665, 862.1120, 862.1145, 864.6400, 862.1160, 862.1170, 862.1600
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code NDW.
- ULTRA-VIOLET GLUCOSE REAGENT by Bio-Analytics Laboratories, Inc.
- MAGNESIUM PROCEDURE by Data Medical Associates, Inc.
- Lithium Micro Volume Electrode, Theophylline, ISE Calibrators 1, 2 and 3, TDM Calibration Set B, Nortrol and AbtroL by Thermo-Electron Corp.
- ADVIA Chemistry Lithium_2 (LITH_2) reagents 11532400 by Siemens Healthcare Diagnostics Inc.
- ADVIA IMS LITHIUM ASSAY by Bayer Healthcare
- SENTINEL LITHIUM ASSAY by Sentinel Ch. Srl
- Diazyme Colorimetric Lithium Assay by Diazyme Laboratories, Inc.
- LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 by Trace America, Inc.
- Atellica CH Lithium_2 (LITH_2) 11532401 by Siemens Healthcare Diagnostics Inc.
- DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE by Siemens Healthcare Diagnostics