Skip to content

New Life Diagnostics Leptospira IgG ELISA Kit

by New Life Diagnostics Inc.

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850078606075 UDI-DI Date13 Apr 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
New Life Diagnostics
Generic Name
Multiple Leptospira species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
Leptospira IgG ELISA Kit, 5009
Primary DI / UDI-DI
00850078606075
GMDN Term
Multiple Leptospira species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
GUDID distribution status
In Commercial Distribution

Other devices from New Life Diagnostics Inc.

See all devices from New Life Diagnostics Inc. →

Properties

  • Single Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No