Lactate Gen.2
4 catalogue numbers from 5401666190, listed by Roche Diagnostics Gmbh, Germany, under Acid, Lactic, Enzymatic Method. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
4catalogue numbers in this listing
1recall
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 | Roche Diagnostics Gmbh, Germany |
|---|---|
| FDA product code | KHP |
| Device type | Acid, Lactic, Enzymatic Method |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1450 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K964457 |
| Record published | 2021-01-18 |
| Record revised | 2023-07-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5401666190 | In distribution | |
| 5171881190 | In distribution | |
| 3183700190 | In distribution | |
| 08057940190 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| StatSensor/StatStrip | Nova Biomedical Corporation | 5 |
| Stat Profile | Nova Biomedical Corporation | 5 |
| Lactate Plus | Nova Biomedical Corporation | 4 |
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 3 |
| i-STAT | Abbott Point OF Care Inc. | 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 Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Roche Diagnostics Gmbh | 510(k) number | 2018-12-17 | Class II | Device Design | New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modular Analytics P/D modules which may have potential medical risk. ***Update: Cobas | 5292 analytical units | 2020-11-02 |
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.