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Diazyme DZ168B-POC

by Diazyme Laboratories, Inc.

Diazyme DZ168B-POC is a device made by Diazyme Laboratories, Inc., listed in FDA GUDID since 3 Nov 2016 (UDI-DI 00817089021082), 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 Number00817089021082 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  • Withdrawn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
Glycated haemoglobin (HbA1c) IVD, reagent
Model / reference
DZ168B-POC
Primary DI / UDI-DI
00817089021082
GMDN term
Glycated haemoglobin (HbA1c) IVD, reagent
GUDID distribution status
In Commercial Distribution

Related devices

Category: Glycated haemoglobin (HbA1c) IVD, reagent

Similar devices in this category

Other devices filed under Glycated haemoglobin (HbA1c) IVD, reagent.

Other devices from Diazyme Laboratories, Inc.

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Properties

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