# Diazyme DZ568A-K03

> Active: European Union. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/diazyme-dz568a-k03>
- Manufacturer: [Diazyme Laboratories, Inc.](https://devicerts.com/manufacturers/diazyme-laboratories-inc) (United States)
- Device class: Class B (EU IVDR)
- EMDN: W01021307 HOMOCYSTEINE
- GMDN: Homocysteine IVD, reagent (53751)

## Registrations and authorizations

- **EUDAMED** · CE/IVDR · European Union · Basic UDI-DI 0817089020807XG · UDI-DI 00817089020870 · registered 2026-10-08 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 00817089020870 · listed 2016-11-03 · status: Listed (GUDID: in commercial distribution)

## Recalls

No recall on record.

## Identity

- Trade name: Diazyme Homocysteine Enzymatic Assay Kit [EUDAMED]; Diazyme [FDA GUDID (AccessGUDID)]
- Generic name: Homocysteine IVD, reagent [FDA GUDID (AccessGUDID)]
- Model / reference: DZ568A-K03 [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00817089020870 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 0817089020807XG [EUDAMED]
- EMDN code: W01021307 [EUDAMED]
- GMDN term: Homocysteine IVD, reagent (53751) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class B [EUDAMED]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Germany [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Contains substances of microbial origin: Yes [EUDAMED]
- Reagent: Yes [EUDAMED]
- Professional testing: Yes [EUDAMED]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Convenience kit: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- IVD kit: No [EUDAMED]
- Self-testing: No [EUDAMED]
- Near-patient testing: No [EUDAMED]
- Companion diagnostics: No [EUDAMED]
- IVD instrument: No [EUDAMED]
- New device: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Diazyme DZ568A-K03, Diazyme Laboratories, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/diazyme-dz568a-k03 (data as of 2026-11-14).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-24
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/diazyme-dz568a-k03.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/diazyme-dz568a-k03
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.