i-STAT
Cartridge, CG4+
Who Else Makes It
Concentrated in Shandong (1), Hunan (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 22 |
| Eaglenos Sciences, Inc. | Nanjing | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Abbott Point OF Care Inc., United States |
|---|---|
| FDA product code | KHP |
| Device type | Acid, Lactic, Enzymatic Method |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1450 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K200492 |
| Record published | 2016-09-09 |
| Record revised | 2025-10-21 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature 2 to 8 °C; Handling environment temperature 2 to 8 °C |
| Packaging | Case of 25, pack of 25 |
| Distribution end date | 2023-08-31 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 03P85-25 | In distribution | |
| 03P85-51 | In distribution | |
| 03P85-50 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| StatSensor/StatStrip | Nova Biomedical Corporation | 5 |
| Stat Profile | Nova Biomedical Corporation | 5 |
| Lactate Gen.2 | Roche Diagnostics Gmbh | 4 |
| Lactate Plus | Nova Biomedical Corporation | 4 |
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 3 |
| Alinity | Abbott Medical | 2 |
| Fora | Fora Care Inc. | 2 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 2 |
| LA Cartridge | LifeHealth, LLC | 2 |
| L-Lactate (LAC) | Randox Laboratories Limited | 2 |
| ABX Pentra Lactic Acid | Horiba ABX SAS | 1 |
| Alinity | Abbott Ireland | 1 |
Showing 12 of 43. All products under Acid, Lactic, Enzymatic Method
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. 1 is recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-01-15 | Class II | No Marketing Application | The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status. CLIA recognizes two types of laboratory tests: waived and non-waived. Different CLIA standards apply to waived and non-waived tests as well | 99,850 | 2021-03-02 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability.
Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.