# Diazyme DZ179A-CAL

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

- Canonical page: <https://devicerts.com/devices/diazyme-dz179a-cal>
- Manufacturer: [Diazyme Laboratories, Inc.](https://devicerts.com/manufacturers/diazyme-laboratories-inc) (United States)
- Device class: IVD General (EU IVDD); Class II (US FDA)
- FDA product code: JIT, GHH
- EMDN: W0103020701 CALIBRATION PLASMA FOR HAEMOSTASIS
- GMDN: D-dimer IVD, calibrator (47348)

## Registrations and authorizations

- **EUDAMED** · CE/IVDD · European Union · Basic UDI-DI B-DZ179A-CALQ8 · UDI-DI D-DZ179A-CALQ8 · registered 2026-10-27 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI D-DZ179A-CALQ8 · listed 2016-11-03 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K112120 · decision 2013-01-24 · decision SESE · status: Active · from GUDID

## Recalls

No recall on record.

## Identity

- Trade name: Diazyme D-Dimer Calibrator Set [EUDAMED]; Diazyme [FDA GUDID (AccessGUDID)]
- Generic name: D-dimer IVD, calibrator [FDA GUDID (AccessGUDID)]
- Model / reference: DZ179A-CAL [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: D-DZ179A-CALQ8 [EUDAMED]; 00817089020535 [FDA GUDID (AccessGUDID)]
- Basic UDI-DI: B-DZ179A-CALQ8 [EUDAMED]
- 510(k) Number: K112120 [FDA GUDID (AccessGUDID)]
- FDA product code: JIT [FDA GUDID (AccessGUDID)]; GHH [FDA GUDID (AccessGUDID)]
- EMDN code: W0103020701 [EUDAMED]
- GMDN term: D-dimer IVD, calibrator (47348) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IVD General [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 862.1150 [FDA GUDID (AccessGUDID)]; 864.7320 [FDA GUDID (AccessGUDID)]
- EU registration type: Legacy device (under a directive) [EUDAMED]
- EU market of registration: Germany [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Contains human tissues or cells: Yes [EUDAMED]
- Professional testing: Yes [EUDAMED]
- 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 animal tissues or cells: No [EUDAMED]
- Contains substances of microbial origin: No [EUDAMED]
- Reagent: No [EUDAMED]
- IVD kit: No [EUDAMED]
- Self-testing: No [EUDAMED]
- Near-patient testing: No [EUDAMED]
- Companion diagnostics: No [EUDAMED]
- IVD instrument: No [EUDAMED]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- 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 DZ179A-CAL, Diazyme Laboratories, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/diazyme-dz179a-cal (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-11-07
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/diazyme-dz179a-cal.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-dz179a-cal
- 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.