L-Lactate (LAC)
2 catalogue numbers from LC3980, listed by Randox Laboratories Limited, United Kingdom, under Acid, Lactic, Enzymatic Method. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Randox Laboratories Limited, United Kingdom |
|---|---|
| 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 |
| Premarket notification | Exempt |
| Record published | 2019-06-03 |
| Record revised | 2023-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LC3980 | In distribution | |
| LC2389 | In distribution |
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 |
| 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 |
| ABX Pentra Lactic Acid | Horiba ABX SAS | 1 |
| Alinity | Abbott Ireland | 1 |
Showing 12 of 43. All products under Acid, Lactic, Enzymatic Method
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.