# i-STAT 03P84-25

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

- Canonical page: <https://devicerts.com/devices/i-stat-03p84-25>
- Manufacturer: [Abbott Point of Care Inc.](https://devicerts.com/manufacturers/abbott-point-of-care-inc) (United States)
- Device class: IVD General (EU IVDD); Class II (US FDA)
- FDA product code: CGL
- EMDN: W0101070201 CREATININE - ELECTRODES
- GMDN: Creatinine/ammonium electrode IVD (30205)

## Registrations and authorizations

- **EUDAMED** · CE/IVDD · European Union · Basic UDI-DI B-00054749000128 · UDI-DI 00054749000128 · registered 2026-10-26 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 00054749000128 · listed 2016-09-09 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K973292 · decision 1997-10-20 · decision SESE · status: Active · from GUDID

## Recalls

- Z-0456-2011 ·  · terminated · initiated 2010-03-17: The i-STAT CREA Cartridges may produce inaccurate (depressed) results at or near the end of the labeled expiry date when stored above 25 degrees for 2 weeks.
- Z-0373-2008 ·  · terminated · initiated 2007-10-18 · matched through shared submission K973292, may concern other models: Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.

## Identity

- Trade name: i-STAT CREA Cartridge [EUDAMED]; i-STAT [FDA GUDID (AccessGUDID)]
- Generic name: Creatinine/ammonium electrode IVD [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: 03P84-25 [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00054749000128 [EUDAMED]; 10054749000125 [FDA GUDID (AccessGUDID)]
- Basic UDI-DI: B-00054749000128 [EUDAMED]
- 510(k) Number: K973292 [FDA GUDID (AccessGUDID)]
- FDA product code: CGL [FDA GUDID (AccessGUDID)]
- EMDN code: W0101070201 [EUDAMED]
- GMDN term: Creatinine/ammonium electrode IVD (30205) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IVD General [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 862.1225 [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

- Single use: Yes [FDA GUDID (AccessGUDID)]
- Contains latex: Yes [FDA GUDID (AccessGUDID)]
- Contains substances of microbial origin: Yes [EUDAMED]
- Near-patient testing: Yes [EUDAMED]
- Professional testing: Yes [EUDAMED]
- 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)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Reagent: No [EUDAMED]
- IVD kit: No [EUDAMED]
- Self-testing: No [EUDAMED]
- Companion diagnostics: No [EUDAMED]
- IVD instrument: No [EUDAMED]
- New device: No [EUDAMED]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: 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: i-STAT 03P84-25, Abbott Point of Care Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/i-stat-03p84-25 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-11-07
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/i-stat-03p84-25.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/i-stat-03p84-25
- 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.