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Nova 1/5/8/10/11/13/14

by Nova Biomedical Corporation

Nova 1/5/8/10/11/13/14 (13203) is a Class II device made by Nova Biomedical Corporation, listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00385480132039), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00385480132039 UDI-DI Date20 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Nova
Generic name
Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Model / Ref / Catalog
1/5/8/10/11/13/14, 13203
Primary DI / UDI-DI
00385480132039
FDA product code
NDW, CDS, JGS, CGZ, JFP, CHL, CFA, CGA, JPI, CEM
GMDN term
Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Device class
Class II
Regulation number
862.3560, 862.1770, 862.1665, 862.1170, 862.1145, 862.1120, 862.1495, 862.1345, 864.6400, 862.1600
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code NDW (Assay, porphyrin, spectrophotometry, lithium).

Other devices from Nova Biomedical Corporation

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Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)