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Diazyme DZ131A-KB1

by Diazyme Laboratories, Inc.

Diazyme DZ131A-KB1 is a device made by Diazyme Laboratories, Inc., listed in FDA GUDID since 3 Nov 2016 (UDI-DI 00817089020979), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817089020979 UDI-DI Date3 Nov 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  • Withdrawn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
Diazyme
Generic name
Lipoprotein A IVD, kit, nephelometry/turbidimetry
Model / reference
DZ131A-KB1
Primary DI / UDI-DI
00817089020979
GMDN term
Lipoprotein A IVD, kit, nephelometry/turbidimetry
GUDID distribution status
In Commercial Distribution

Related devices

Category: Lipoprotein A IVD, kit, nephelometry/turbidimetry

Other devices from Diazyme Laboratories, Inc.

See all devices from Diazyme Laboratories, Inc. →

Properties

  • Contains latex
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)